Fertility awareness-based methods of family planning

Journal Pre-proof Fertility Awareness-Based Methods of Family Planning Rebecca Simmons, Victoria Jennings

PII:

S1521-6934(19)30179-8

DOI:

https://doi.org/10.1016/j.bpobgyn.2019.12.003

Reference:

YBEOG 1996

To appear in:

Best Practice & Research Clinical Obstetrics & Gynaecology

Received Date: 8 November 2019 Revised Date:

4 December 2019

Accepted Date: 10 December 2019

Please cite this article as: Simmons R, Jennings V, Fertility Awareness-Based Methods of Family Planning, Best Practice & Research Clinical Obstetrics & Gynaecology, https://doi.org/10.1016/ j.bpobgyn.2019.12.003. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Ltd.

Fertility Awareness-Based Methods of Family Planning

Authors: Rebecca Simmons1, Victoria Jennings2 Corresponding author: Rebecca Simmons

Address: 1. Division of Family Planning Department of Obstetrics & Gynecology University of Utah 30 N. 1900 East Salt Lake City, Utah 84132 United States [email protected] 2. Institute for Reproductive Health Georgetown University Medical Center 3300 Whitehaven, #1200 Washington, DC 20009 United States

1

ABSTRACT Fertility awareness-based methods of family planning (FABMs) involve monitoring various signs and symptoms of fertility during the menstrual cycle to identify the “fertile window,” or the days of the cycle when unprotected intercourse is most likely to result in pregnancy. Signs and symptoms include menstrual cycle length, basal body temperature, urinary hormone measurements, and/or cervical fluid and may be used alone or in combination. Fertility signs reflect both physiologic changes during the menstrual cycle and the life-cycle of the ovum and sperm. Women learn to observe or measure and interpret these signs according to the instructions of their chosen FABM and avoid unprotected intercourse on fertile days. FABMs are appropriate for those who choose to use them, are able and willing to observe one or more fertility signs, and are in relationships that support use of a coitusrelated method such as a condom or abstaining from intercourse on fertile days.

Key words: fertility awareness-based method, natural family planning, menstrual cycle, fertility signs, contraception

2

A. FERTILITY AWARENESS-BASED METHODS OF FAMILY PLANNING Fertility awareness-based methods (FABMs) are a class of contraceptive methods whose users determine their daily fertility based on their personal physiological data. The underlying contraceptive principle of FABMs is that an individual can reduce the probability of pregnancy by interpreting this information and then choosing to either abstain from sexual intercourse or use coitus-based methods (condoms, diaphragms, cervical caps, withdrawal, spermicides, sponges, films) on fertile days. While often used as a singular term for this class of methods, FABMs are actually comprised of several different methods, each relying on different method rules and interpretation of various fertility signs. These fertility signs reflect both physiologic changes during the menstrual cycle and the functional life-span of the ovum and sperm. Guidance related to sexual activity during the fertile time distinguishes FABMs from the more commonly-known term “Natural Family Planning” (NFP): while FABMs can be used in conjunction with other methods (usually barrier methods), users of NFP are abstinent during the fertile period and do not rely on physical or hormonal barriers to prevent pregnancy [1]. NFP approaches are most commonly used in religious contexts that prohibit the use of other contraceptive methods. Familiarity with both terms and an understanding of the difference in their application can be useful for clinicians who serve diverse clientele. FABMs are appropriate for individuals who choose to use them, are able and willing to regularly observe one or more fertility signs and are in relationships that support use of a coitus-related method, such as a condom, or abstaining from intercourse on fertile days. As a component of FABM use, clinicians should recognize that some patients who identify as women are not physically capable of pregnancy and that some who identify as male may

3

have particular counseling needs. It is also important to recognize the role of the male partner in FABM use, given the need to abstain or use a condom on fertile days. This chapter describes the physiologic basis of FABMs, provides an overview of existing, evidence-based FABMs, discusses their effectiveness for pregnancy prevention, identifies indications for using FABMs in a variety of circumstances, relays advantages and barriers related to FABM use, and identifies aspects important for inclusion of FABMs in clinical settings. This chapter also discusses recent advances in FABMs, potential implications, and possible future research directions. B. PHYSIOLOGIC BASIS OF FABMs There is a limited window within a given menstrual cycle in which an individual can become pregnant. Ovulation occurs on a single day within each cycle, and the ovum remains viable for fertilization for approximately 12-24 hours [2]. Sperm released into the vaginal canal prior to ovulation can survive within the female reproductive tract for up to five days [3]. In combinate, this results in an estimated six-day window for conception to occur, with probabilities of pregnancy highest in the two days prior to ovulation (~30%), then falling to 8-10% on the date of ovulation, and zero probability of conception on subsequent days [3] This period is commonly referred to as the “fertile window.” FABMs utilize observation of physiologic signs and symptoms to identify the fertile window, which subsequently can be used in sexual activity decision-making during the fertile window, to either avoid or achieve pregnancy. As individuals do not always ovulate on the same day each cycle, identified fertile windows for pregnancy prevention purposes are generally conservative and usually longer than six days to ensure variability in the window is appropriately captured.

4

Different FABMs rely on various physiologic signs and symptoms, used on their own or in combination with other signs, to predict or identify the fertile window. These signs and symptoms include: • Basal body temperature (BBT), or the temperature of the body at rest, is bi-phasic, lower during the follicular phase and approximately 0.3°C (0.5°F) higher during the luteal phase. Following ovulation, the corpus luteum, a dynamic temporary endocrine gland in the ovary, forms to improve endometrial vascularity and promote increased serum progesterone concentrations, both of which are necessary to support a potential pregnancy [4]. These functions result in a rise in basal body temperature that continues until approximately 1-2 days prior to the onset of menstruation [5]. While identifying the temperature shift does not identify the onset of the fertile window, a continuous observation of an increased basal body temperature can be used to confirm the occurrence of ovulation and signal the end of the fertile window. Additionally, BBT can be extrapolated from prior cycles using algorithms to help determine prospective fertile window parameters. To collect BBT correctly, individuals must take their temperature at approximately the same time every day, immediately upon waking. • Cervical fluid (also referred to as cervical mucus or cervical secretions), is an aqueous secretion produced in the endocervical canal, mainly comprised of water, fatty acids, carbohydrates, cholesterols, proteins and inorganic ions [6]. Cervical fluid acts as a moderator within the reproductive tract, promoting or prohibiting the passage of sperm through compositional changes that are responsive to the presence of hormones, specifically estradiol and progesterone [6]. Cervical fluid is initially produced after the onset of menstruation and typically has a tacky, viscid consistency [7]. As the cycle progresses, the composition of cervical fluid changes. Cervical fluid becomes clear, stretchy, and abundant two or three days prior to, during, and 5

immediately following ovulation, consistent with the onset and end of the fertile window [7, 8]. Following ovulation, cervical fluid again becomes viscid and reduces or disappears completely for the remainder of the luteal phase. Observation of changes in cervical fluid can support identification of both the onset and completion of the fertile window. • Menstrual cycle length, or the time between the onset of one menstrual cycle and another, can also be used to identify the fertile window. While cycle length varies among people and an individual’s cycle length may shift from one cycle to another, ovulation is most likely to occur 9-16 days prior to the end of the cycle [9, 10]. Composite data on cycle lengths and ovulation has been utilized to develop rules for estimated fertile windows for women with given cycle lengths, such as modeling done on the Standard Days Method, which identified a likely fertile window of days eight through 19 among women with cycles between 26 and 32 days in length [11]. Additionally, new modeling approaches have incorporated individual cycle data, including individual within-cycle variability, into big data analytics to provide personalized estimations of the fertile window [12]. • Urinary assays for reproductive hormones, primarily for luteinizing hormone (LH), but also estradiol and pregnanediol glucuronide levels, can also be used to identify points in the fertile window [13-15]. To track this information, individuals collect urine samples and track the presence and/or amount of reproductive hormone identified to determine whether ovulation has occurred. As excreted hormones, such as LH, occur or increase immediately prior to ovulation, these methods can be used to identify the completion of the fertile period but may not be sufficient to identify its onset. C. OBSERVATION OF FERTILE SIGNS AND FABMs Different FABMs involve observation of one or more fertile signs, and each provides different “rules” for applying these observations in determining the onset and end of the

6

fertile window. Modern FABMs with an existing research evidence-base specifically for unintended pregnancy rates are described below [16]. Some methods described use proprietary names, as many FABMs are specific approaches without generic counterparts. FABMs with study outcomes restricted to conception are not included here, as these data are insufficient to extrapolate for use in pregnancy prevention. Information about specific FABMs, including the time required to learn, the signs and symptoms tracked, and existing resources for counseling and education for each can be found in Table 1. Illustrations demonstrating how different FABMs are used can be viewed in Figure 1. • The Billings Ovulation Method is based on observation of cyclic changes in cervical fluid [17-19]. Users are instructed to avoid unprotected intercourse during menses and to have unprotected intercourse no more than every other day until the appearance of fertile-type fluid, thus minimizing the potential of misinterpreting semen as fertile-type fluid. Individuals avoid unprotected intercourse when fertile-type fluid is present but can resume unprotected intercourse on the third day following the cessation of fertile-type fluid. While observation of cervical fluid can be hindered by secretions caused by certain infections, Billings Ovulation Method users can also be taught how to differentiate cervical fluid from symptoms of infection and to seek care immediately if these symptoms occur. Billings Ovulation Method users usually record their fertile signs on a chart provided for this purpose. • Dynamic Optimal Timing, or Dot, is an app-based method that uses menstrual cycle length to algorithmically determine the fertile window [12, 20, 21]. Dot was developed based on a Bayesian analysis for several thousand menstrual cycles from a World Health Organization study combined with hormonal and ultrasound data from studies conducted in the US [12]. Designed for individuals with cycles between 20 and 40 days long, it requires a person to enter their menstrual cycle start dates each cycle. When the app is first initiated,

7

individuals using Dot for pregnancy prevention are shown a conservative fertile window, approximately 16 days, for that cycle. As more cycles are entered over time, the app incorporates individual cycle information into its calculation of the fertile window, thus potentially narrowing or expanding the fertile window, based on new information. To use Dot for contraceptive purposes, individuals must enter their period start date each month and check the app (or receive notifications) for information on their daily risk of pregnancy (High/Low). Dot users receive instruction on how to use the method through the app. Dot will be available on iPhone and Android devices in 2020. • The Marquette Method has several variants, but the most common approach involves individuals both observing their cervical fluid and using a home-based urinary hormone test, the Clearblue Fertility monitor, to identify the rise in luteinizing hormone and progesterone [22-24]. To begin use of the Marquette method, eligible individuals (people with cycles between 22-42 days) consider themselves fertile on day six of their menstrual cycle. Users then monitor both their cervical fluid and their urinary hormones. The end of the fertile period is identified by the last day of fertile (peak) cervical fluid or the last day that the monitor identifies the fertile period (whichever comes last). Users are instructed to wait three full days following their last fertile marker before having unprotected sex. Users record cervical fluid observations and hormone test results on a chart, app, or on a webtracking system developed for this purpose. Most individuals who use this method have been instructed by trained providers who have been certified by Marquette University. • Natural Cycles is an app-based method that primarily uses BBT, along with menstrual cycle history, to algorithmically identify the fertile window [25-27]. To use, individuals must take their BBT daily and enter it (or upload it, if the thermometer syncs with the app) into the app. Using BBT, the app provides red (fertile) and green (infertile) information about daily fertility. Individuals are instructed to avoid or have protected sex on fertile days,

8

depending on their fertility intentions. Most people using this method receive information about how to use it either through the Natural Cycles website or within the app. • The Standard Days Method (SDM) requires the user to track menstrual cycle length and avoid unprotected intercourse on days eight through 19 [28-30]. To use SDM, individuals should have menstrual cycles between 26 and 32 days long. To initiate SDM use, it is not necessary for users to know the length of their prior cycles, although if an individual knows they have cycles outside the method range, they should consider another method. If a user has more than one cycle shorter than 26 days or longer than 32 days over a 12-month period while using SDM, they no longer meet the criteria for method use. SDM users can track their cycles by using CycleBeads, a tool available either as a smart phone app (CycleBeads), or as physical beads that helps individuals monitor their cycle lengths and readily see their fertile days; however, users do not need to use CycleBeads, but can track cycle days on a calendar, counting days from the onset of menses to identify days eight through 19. The CycleBeads app sends alerts to users regarding their fertile window, impending menses, and cycle lengths [31]. In a six-country study of CycleBeads integration into family planning services, 90% of users [n=1646] reported that they found CycleBeads easy to use and would recommend the tool [30]. • The Symptothermal (double-check) Method combines the menstrual cycle lengths with both tracking of cervical fluid and basal body temperature to determine the parameters of the fertile window [32-34]. There are several guidelines for using this method, all of which are based on the appearance of fertile-type cervical fluid as the indicator for the onset of the fertile window (moderated by the length of previous cycles) and the temperature rise as the indicator for ovulation occurrence [32, 35]. Users are instructed to record both basal body temperature and cervical fluid daily, as well as additional optional indicators such as cervical positioning, on a chart provided for this purpose [36]. Individuals use both fertile-

9

type cervical fluid and previous cycle history as indicators for the onset of the fertile period. The end of the fertile period is identified by both a change in cervical fluid and at least three continuous days of higher temperatures (at least 0.4 degrees higher than preovulatory temperatures) following a BBT shift. Users are instructed to wait three full days after seeing both fertile-type cervical fluid and a temperature shift (whichever comes last) before having unprotected sex. In addition to Symptothermal Method charts, which are available both physically and digitally (through charting platform apps such as Lady Cycle, Kindara, and Sympto), a smart phone app, CycleProGo, is available to help users track and interpret their fertility signs. Instruction for using the Symptothermal Method is typically offered by a trained provider. • The TwoDay Method also involves observing cervical fluid, with the user required to

detect the presence or absence of fluid, rather than interpreting fluid characteristics [37, 38]. According to TwoDay Method guidelines, users should check for cervical fluid at the vulva twice each day after the cessation of menses. Users are instructed to avoid unprotected intercourse on any day with cervical fluid present and any day following a day with cervical fluid. The fertile window is defined as the total time in which cervical fluid is present either on the day of measurement or the previous day. This method considers the likelihood that pre-ovulatory non-fertile secretions will be followed by fertile-type fluid and ovulation within the five-day span prior to ovulation, that the presence of cervical fluid indicates fertility, and that the cessation of cervical fluid following ovulation marks the end of the fertile window. TwoDay Method users can record the presence of cervical fluid on a calendar or a smart phone app, 2DayMethod. Typically, individuals learn the TwoDay method through the website or through the app. D. EFFECTIVENESS OF FABMs

10

The efficacy of FABMs is often misinterpreted by organizations and providers. Due to the small numbers of users, distinct FABMs have historically been aggregated in populationbased studies assessing their efficacy, such as analyses of the National Survey for Family Growth [39] . This grouping has often included the “rhythm method,” which is an approach to avoiding pregnancy that was proposed in the 1920s and persists in certain communities today [40, 41]. While the rhythm method has distinct rules for use, studies of its efficacy are limited and considered of low quality [16]. The grouping of FABMs with the rhythm method has resulted in the misperception that all FABMs are variants of the rhythm method and thus are not efficacious or based on scientific evidence. This, in turn, has led many to categorize these methods as “traditional” methods of contraception, rather than modern methods that are each based on scientific understanding of fertility and subject to contraceptive efficacy studies [42, 43]. This problem of mis-categorization and nomenclature is further compounded by similar confusion among individuals who respond in surveys that they use the “rhythm method,” “natural family planning,” or “fertility awareness method,” yet do not have accurate information about their fertility or formal knowledge of any particular method and thus cannot be said to actually be using a FABM [44, 45]. Current FABMs meet the criteria of modern methods of contraception developed by the World Health Organization, which classifies modern methods as those with a “sound basis in reproductive biology, a precise protocol for correct use and evidence of efficacy under various conditions based on appropriately designed studies” [42]. As modern methods, each FABM has distinct perfect and typical use efficacy rates, though studies on efficacy and effectiveness for these methods have been more limited than other methods of contraception. A recent review of existing efficacy studies across various FABMs found a range of perfectuse pregnancy rates from 0.4-12.1, and a range of typical-use pregnancy rates from 1.8-33.6, depending on the method [16]. In general, low rates of unintended pregnancy with perfect

11

use indicate that these methods can accurately identify the fertile window. Higher pregnancy rates with typical use are more varied, suggesting that aspects such as ease of use, motivation, and self-efficacy to avoid pregnancy affect results. Information about perfect- and typical-use efficacy rates and ranges for individual FABMs, as well as other user-initiated contraceptive methods, can be found in Figure 2. E. ADVANTAGES AND BARRIERS TO FABM USE FABMs have several distinct advantages within the contraceptive method mix. They are nonhormonal options for individuals who cannot or do not wish to use hormonal methods. FABMs can be utilized as dual methods by individuals using barrier methods, providing additional information around risk of pregnancy that could inform behavior. These methods often require initial education and training that result in skills that individuals can utilize over their reproductive lives. FABMs can be used to prevent as well as achieve pregnancy, allowing for seamless transitions in pregnancy intentions. Finally, there is inherent benefit in body literacy, and organizations such as the American College of Obstetrics and Gynecologists have identified the menstrual cycle as a health vital sign: individuals’ ability to understand and interpret their cycle data has potential to improve reproductive health [46]. As is the case for any contraceptive method, FABMs are not appropriate for all people. FABMs rely on partner cooperation and are thus not recommended for people in coercive or unsupportive relationships where condom or sexual activity negotiation would be a challenge [47]. Further, as FABMs rely on physiological signs and symptoms, individuals with underlying reproductive health conditions may have trouble accurately identifying and interpreting these, as they often change with underlying pathophysiology. Individuals who have recently given birth or those who are currently breastfeeding may also find FABM use challenging. Finally, while many individuals find satisfaction and value in learning and

12

applying FABM skills, these methods do require behavioral adherence and, as such, might not be ideal methods for people who prioritize “set it and forget it” as an important component of their method selection. F. COUNSELING POINTS Despite recent interest in and increased demand for FABMs, these methods have largely been left out of the clinical contraceptive offering [48, 49]. This is due to both system and behavioral factors. Currently, there are no standardized clinical offerings for FABMs as a method class. The few existing provider trainings, materials and resources are specific to a limited number of individual FABMs, which primarily use NFP guidelines rather than FABM guidelines and were not developed for implementation in general clinical settings [50]. Guidance is also lacking about how to counsel clients regarding their selection of a particular FABM and how to educate/train individuals who wish to adopt these methods within contraceptive visit times for new and existing clients. Finally, there is no existing guidance that updates providers about emerging FABMs or about how to counsel clients who are currently using apps or approaches that are not evidence-based. Lack of comprehensive guidance for providers about FABM provision within clinical practice continues to limit availability. Behavioral barriers to FABM integration into clinical settings include addressing providers’ misconceptions about use of these methods for pregnancy prevention. Providers report barriers to their provision that largely center around their beliefs that these methods are ineffective, that there is not demand for these methods, and that these methods are too challenging for clients to use or incorporate into their daily lives [48, 49]. To ensure that clinical method offerings include FABMs, these barriers must also be addressed.

13

Contraceptive clients view providers as one of the most important resources for method selection [51]. Without clinical training or guidance on FABM methods, it is likely that clients will select faux-methods, or apps/technologies that appear to be FABMs, but lack evidence or are based on outdated assumptions of human fertility, such as the idea that ovulation always occurs on day 14 of the menstrual cycle. A study of 40 existing fertility apps and technologies that claimed to be suitable for pregnancy prevention found that only 4 could accurately identify the fertile window [52]. Since the FDA has historically had limited regulation around fertility apps (unless they have a corresponding piece of technology, such as a proprietary thermometer or software), there has been little governing oversight for the claims that can be made around many fertility apps/technologies. Although the FDA has recently begun to emphasize regulation of digital health, this represents an emergent issue for clients, who may experience unintended pregnancy from relying on approaches that appear to be, but are not actually, evidence-based FABMs. Clinicians are an as-yet-untapped resource in ensuring FABM users have appropriate guidance, education and training on how to identify, select and use actual methods appropriately to avoid pregnancy. As contraceptive efficacy is improved when individuals are provided access to the full range of methods [53], clinicians interested in offering FABMs should consider inclusion of more than one FABM in their counseling practice. While there is no existing research on best practices for clinical guidance around FABM selection, some decisional considerations in counseling could include: • the types of physiological signs individuals are comfortable observing and recording regularly; • whether the individual wishes to interpret their own data or have the fertile window provided to them via algorithm;

14

• how users wish to record or compile their information (e.g., paper chart, website, smartphone app, or no charting); • perfect- and typical-use efficacy of particular FABMs; • cost of both learning and using different FABMs; • the timeframe required to learn a method and use it appropriately. Additionally, clinicians could ascertain whether or not motivations to use these methods include religious beliefs, which could guide a conversation about sexual behavior during the fertile window. Individuals planning to use FABMs should be provided their choice of barrier methods in the same contraceptive visit, to support behavior during the fertile window. Clients who have recently discontinued hormonal contraceptives should be counseled to use barrier methods continuously until their cycles become regular [27]. Other support, such as advanced provision of emergency contraception, should also be made available based on client preferences, while also counseling clients that taking emergency contraception could potentially affect the length of their next cycle [51, 54]. G. DEMAND FOR AND USE OF FABM METHODS Compared to many other methods of contraception, such as the contraceptive pill, demand for FABM methods is low. An estimated 3% of contraceptive users in the United States report using FABM methods [39]. It is likely that reasons for lower use are multi-factorial. First, demand may be impacted by the higher level of behavioral adherence required to use these methods correctly compared to other methods. While some individuals find value in tracking their physiology, the requirement to closely monitor and make behavioral decisions around daily fertility does not have universal appeal. Further, both real and misconceived perceptions of FABM efficacy likely play a role in use and demand. Compared to methods such as the intrauterine device or contraceptive

15

implant, FABMs do have higher pregnancy rates [see Figure 2]. While the typical use pregnancy rates of many hormonal methods, such as the contraceptive pill, are comparable to typical use pregnancy rates of some individual FABMs, the traditional grouping of all FABMs, including the rhythm method, together in surveillance data has further emphasized cultural and clinical perceptions that these methods have very low efficacy, despite the limitations of these interpretations. Additionally, while emerging studies have identified other important components of contraceptive method selection, such as personal values, relationship dynamics, and past experiences with contraceptive methods, traditional approaches to contraceptive counseling have largely relied on the tiered efficacy approach, wherein providers discuss methods in accordance with their efficacy. As FABMs are also lumped together as a method class within the tiered efficacy approach, their discussion or offering is usually limited. Additionally, as previously mentioned, low provider education and training on how to counsel or educate patients on individual FABMs also contributes to gaps in their offering within clinical settings. Nonetheless, there is evidence that demand for FABM is increasing. In 2008, prevalence of FABM use was estimated at around 1% in the National Survey for Family Growth [55]. The threefold increase in FABM use reported in more recent waves of this survey likely reflects new demand, as well as the emergence and visibility of new FABM offerings. Finally, millions of people currently use app- or tech-based fertility trackers and while the proportion of people reporting that they wish to use this technology as contraception is likely a small subgroup compared to those wishing to track or conceive, preliminary evidence suggests that this demographic is also growing [44]. H. EMERGING AREAS IN FABMs

16

New opportunities are emerging for FABMs along multiple fronts. Smart-phone technology capabilities have and will likely continue to contribute both to the advent of new methods, such as app-based methods like Natural Cycles and Dot, and easier usability of existing methods, including app-based charting platforms, reminder notifications to improve adherence, and new avenues for partner communication, such as text-based notifications that can be shared with sexual partners. Simultaneously, scientific advances have improved the sensitivity and specificity of diagnostic fertility tests, such as an expanded offering of urinary assays, to improve decisionmaking accuracy. In a similar vein, new medical technologies are currently being developed, including wearable devices that could increase capability to detect physiologic symptoms such as cervical fluid, or improve existing technologies, such as basal body thermometers that take temperature readings while the user is sleeping. As new approaches to improving or expanding FABMs emerge, new challenges also arise in navigating their use. Traditionally, contraceptive methods have been developed through federal funding streams, such as the National Institutes of Health, through philanthropic foundations, or through pharmaceutical collaborations with academic/clinical institutions. Currently, the majority of emerging fertility technology being developed is supported by investor funding, with limited allowances around sharing proprietary information about their development. This privatized approach is symptomatic of the existing differential between increasing consumer demand for these methods and the challenge of funding research and development for FABMs: as federal and philanthropic entities have provided limited support for FABMs, the private sector has embraced them. This presents new, important challenges around issues such as efficacy research. Rigorous contraceptive efficacy studies are traditionally expensive and lengthy and may not be appealing to investors. Maintaining consumer confidence, safety and adhering to best practices for

17

contraceptive method development in a privatized environment will likely require new research approaches, as well as new collaborations between private and public sectors. Additionally, traditional FABMs have been largely reliant on certified or experienced instructors to guide interested individuals through the necessary education to collect and interpret fertility information. New FABMs and technologies have disrupted this approach, providing users with a variety of fertility information without requiring additional support. While this is an inherent boon to the expansion of these methods, it also may result in a higher proportion of individuals using methods incorrectly, as fertility literacy is quite low in the general population [44, 45, 56]. I. FUTURE RESEARCH DIRECTIONS The increased demand for FABMs also results in an ever-increasing need for additional research on these methods. There is an urgent need to conduct rigorous research on existing and emerging methods. While there is an evidence base for the FABMs discussed in this chapter, each method would benefit from additional research on topics, such as the user characteristics associated with successful vs. unsuccessful use; efficacy of and satisfaction with these methods within different populations (e.g., adolescents, individuals with chronic health conditions, sexual minority women, etc.); and assessments of how these methods affect relationships, such as how partner communication and support influences continuation, satisfaction, and successful use. Among methods currently in development, there is a need for new strategies to accommodate the different development pathways of these methods, including identifying and testing ways to support rigorous efficacy research on privatized and proprietary products and approaches. Additionally, on the user end, there is a need to assess how and why users

18

select specific methods, in order to identify ways to educate and inform potential consumers on which approaches align with scientific evidence. There is also a need to identify best practice strategies for the inclusion of and counseling for FABMs in the clinical setting, as well as research on how to best incorporate FABM counseling into the realities and constraints of clinic visits. Further, research could examine ways to reduce provider misperceptions about FABMs and increase their selfefficacy to counsel clients in these methods. Other interesting areas of research could include clinical studies assessing how menstrual cycle data could be incorporated into broader reproductive health, such as studies that examine how these data could be utilized to appropriately identify or assess underlying reproductive health problems. Research aimed at improving approaches to fertility measurement, including the development of new hormonal assays, also has the potential to improve FABMs. Finally, more research is needed to understand how FABMs fit within the contraceptive method mix. Studies assessing aspects such as comparative satisfaction between contraceptive methods or identifying the pathways by which women select an FABM could improve method counseling. Research about utilization and efficacy of FABMs in conjunction with other methods, including condoms, withdrawal, spermicides, emergency contraception, and other barrier methods, as well as about the dynamics of dual-method use could also improve FABM provision and use. I. SUMMARY Demand for and availability of FABMs has increased within the last decade, particularly with the availability of fertility apps. As new app-based methods and supportive fertility

19

technologies continue to push FABMs into the mainstream, there is increasing need for further education on, awareness of, support for, and research around these methods.

20

ACKNOWLEDGEMENTS This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors would like to acknowledge the critical roles of both Ms. Madeline Mullholland and Ms. Jami Baayd in providing graphic and editorial support in the creation of this article.

CONFLICTS OF INTEREST Dr. Simmons has no conflicts of interest to declare. Dr. Jennings is a grantee of the United States Agency for International Development and several foundations to conduct research on FABMs. Dr. Jennings is related to but receives no income from the owner of Cycle Technologies (the company which sells CycleBeads and developed Dot).

PRACTICE POINTS:

• Counseling and provision of fertility awareness-based methods should also include counseling on and provision of the person’s preferred barrier method(s) at the clinic visit, to ensure that individuals have support to navigate sexual activity during the fertile window.

• Consistent with recommended best practices for contraceptive counseling, providers counseling people on fertility awareness-based methods should also offer provision of or prescription for emergency contraception to individuals who want it.

RESEARCH AGENDA

• User characteristics associated with successful vs. unsuccessful use of fertility awareness-based methods;

21

• Efficacy of and satisfaction with fertility awareness-based methods within different populations (e.g., adolescents, individuals with chronic health conditions, sexual minority women, etc.); • Assessments of how fertility awareness-based methods affect relationships, including how partner communication and support influences continuation, satisfaction, and successful use. • Identify best practice strategies for the inclusion of and counseling for FABMs in the clinical setting, as well as research on how best incorporate FABM counseling into the realities and constraints of clinic visits. • Examine ways to reduce provider misperceptions about fertility awareness-based methods and increase their self-efficacy to counsel clients in these methods. • Utilization and efficacy of fertility awareness-based methods in conjunction with other methods, including condoms, withdrawal, spermicides, emergency contraception, and other barrier methods.

22

REFERENCES [1] World Health Organization. Natural family planning: a guide to provision of services. 1988. [2] Wilcox AJ, Weinberg CR, Baird DD. Timing of sexual intercourse in relation to ovulation. Effects on the probability of conception, survival of the pregnancy, and sex of the baby. N Engl J Med. 1995;333(23):1517-21. [3] Wilcox AJ, Dunson D, Baird DD. The timing of the "fertile window" in the menstrual cycle: day specific estimates from a prospective study. BMJ. 2000;321(7271):1259-62. [4] Baerwald AR, Adams GP, Pierson RA. Form and function of the corpus luteum during the human menstrual cycle. Ultrasound Obstet Gynecol. 2005;25(5):498-507. [5] Su HW, Yi YC, Wei TY, Chang TC, Cheng CM. Detection of ovulation, a review of currently available methods. Bioeng Transl Med. 2017;2(3):238-46. [6] Han L, Taub R, Jensen JT. Cervical mucus and contraception: what we know and what we don't. Contraception. 2017;96(5):310-21. [7] Bigelow JL, Dunson DB, Stanford JB, Ecochard R, Gnoth C, Colombo B. Mucus observations in the fertile window: a better predictor of conception than timing of intercourse. Hum Reprod. 2004;19(4):889-92. [8] Scarpa B, Dunson DB, Colombo B. Cervical mucus secretions on the day of intercourse: an accurate marker of highly fertile days. Eur J Obstet Gynecol Reprod Biol. 2006;125(1):728. [9] Bull JR, Rowland SP, Scherwitzl EB, Scherwitzl R, Danielsson KG, Harper J. Realworld menstrual cycle characteristics of more than 600,000 menstrual cycles. NPJ Digit Med. 2019;2:83.

23

[10] Sohda S, Suzuki K, Igari I. Relationship Between the Menstrual Cycle and Timing of Ovulation Revealed by New Protocols: Analysis of Data from a Self-Tracking Health App. J Med Internet Res. 2017;19(11):e391. [11] Arévalo M, Sinai I, Jennings V. A fixed formula to define the fertile window of the menstrual cycle as the basis of a simple method of natural family planning. Contraception. 1999;60(6):357-60. [12] Li D, Heyer L, Jennings VH, Smith CA, Dunson DB. Personalised estimation of a woman’s most fertile days. The European Journal of Contraception & Reproductive Health Care. 2016;21(4):323-8. [13] Blackwell LF, Vigil P, Alliende ME, Brown S, Festin M, Cooke DG. Monitoring of ovarian activity by measurement of urinary excretion rates using the Ovarian Monitor, Part IV: the relationship of the pregnanediol glucuronide threshold to basal body temperature and cervical mucus as markers for the beginning of the post-ovulatory infertile period. Hum Reprod. 2016;31(2):445-53. [14] Ecochard R, Leiva R, Bouchard T, Boehringer H, Direito A, Mariani A, et al. Use of urinary pregnanediol 3-glucuronide to confirm ovulation. Steroids. 2013;78(10):1035-40. [15] Leiva RA, Bouchard TP, Abdullah SH, Ecochard R. Urinary luteinizing hormone tests: which concentration threshold best predicts ovulation? Frontiers in public health. 2017;5:320. [16] Urrutia RP, Polis CB, Jensen ET, Greene ME, Kennedy E, Stanford JB. Effectiveness of fertility awareness–based methods for pregnancy prevention: A systematic review. Obstetrics & Gynecology. 2018;132(3):591-604. [17] World Health Organization. A prospective multicentre trial of the ovulation method of natural family planning. I. The teaching phase. Fertility and Sterility. 1981;36(2):152-8. [18] World Health Organization. A prospective multicentre trial of the ovulation method of natural family planning. II. The effectiveness phase. Fertility and Sterility. 1981;36(5):591-8.

24

[19] Bhargava H, Bhatia J, Ramachandran L, Rohatgi P, Sinha A. Field trial of billings ovulation method of natural family planning. Contraception. 1996;53(2):69-74. [20] Jennings VH, Haile LT, Simmons RG, Fultz HM, Shattuck D. Estimating six-cycle efficacy of the Dot app for pregnancy prevention. Contraception. 2019;99(1):52-5. [21] Jennings V, Haile LT, Simmons RG, Spieler J, Shattuck D. Perfect-and typical-use effectiveness of the Dot fertility app over 13 cycles: results from a prospective contraceptive effectiveness trial. The European Journal of Contraception & Reproductive Health Care. 2019;24(2):148-53. [22] Fehring RJ, Schneider M. Effectiveness of a natural family planning service program. MCN: The American Journal of Maternal/Child Nursing. 2017;42(1):43-9. [23] Fehring RJ, Mu Q. Cohort efficacy study of natural family planning among perimenopause age women. Journal of Obstetric, Gynecologic & Neonatal Nursing. 2014;43(3):351-8. [24] Fehring RJ, Schneider M, Raviele K, Rodriguez D, Pruszynski J. Randomized comparison of two Internet-supported fertility-awareness-based methods of family planning. Contraception. 2013;88(1):24-30. [25] Berglund Scherwitzl E, Lundberg O, Kallner HK, Danielsson KG, Trussell J, Scherwitzl R. Perfect-use and typical-use Pearl Index of a contraceptive mobile app. Contraception. 2017;96(6):420-5. [26] Berglund Scherwitzl E, Gemzell Danielsson K, Sellberg JA, Scherwitzl R. Fertility awareness-based mobile application for contraception. The European Journal of Contraception & Reproductive Health Care. 2016;21(3):234-41. [27] Bull J, Rowland S, Lundberg O, Berglund-Scherwitzl E, Gemzell-Danielsson K, Trussell J, et al. Typical use effectiveness of Natural Cycles: postmarket surveillance study

25

investigating the impact of previous contraceptive choice on the risk of unintended pregnancy. BMJ open. 2019;9(3):e026474. [28] Arévalo M, Jennings V, Sinai I. Efficacy of a new method of family planning: the Standard Days Method. Contraception. 2002;65(5):333-8. [29] Burkhart MC, de Mazariegos L, Salazar S, Lamprecht VM. Effectiveness of a standardrule method of calendar rhythm among Mayan couples in Guatemala. International Family Planning Perspectives. 2000;26(3):131-6. [30] Gribble JN, Lundgren RI, Velasquez C, Anastasi EE. Being strategic about contraceptive introduction: the experience of the Standard Days Method. Contraception. 2008;77(3):147-54. [31] Haile LT, Fultz HM, Simmons RG, Shelus V. Market-testing a smartphone application for family planning: assessing potential of the CycleBeads app in seven countries through digital monitoring. Mhealth. 2018;4:27. [32] Frank-Herrmann P, Heil J, Gnoth C, Toledo E, Baur S, Pyper C, et al. The effectiveness of a fertility awareness based method to avoid pregnancy in relation to a couple's sexual behaviour during the fertile time: a prospective longitudinal study. Hum Reprod. 2007;22(5):1310-9. [33] Frank-Herrmann P, Freundl G, Gnoth C, Godehardt E, Kunert J, Baur S, et al. Natural family planning with and without barrier method use in the fertile phase: efficacy in relation to sexual behavior: a German prospective long-term study. Advances in contraception. 1997;13(2-3):179-89. [34] Groups ENFPS. European multicenter study of natural family planning (1989–1995): efficacy and drop-out. Advances in Contraception. 1999;15:69-83.

26

[35] Frank-Herrmann P, Gnoth C, Baur S, Strowitzki T, Freundl G. Determination of the fertile window: reproductive competence of women--European cycle databases. Gynecol Endocrinol. 2005;20(6):305-12. [36] Weschler T. Taking charge of your fertility: The definitive guide to natural birth control, pregnancy achievement, and reproductive health: William Morrow Paperbacks; 1995. [37] Arévalo M, Jennings V, Nikula M, Sinai I. Efficacy of the new TwoDay Method of family planning. Fertility and sterility. 2004;82(4):885-92. [38] Sinai I, Arévalo M. It’s all in the timing: coital frequency and fertility awareness-based methods of family planning. Journal of biosocial science. 2006;38(6):763-77. [39] Polis CB, Jones RK. Multiple contraceptive method use and prevalence of fertility awareness based method use in the United States, 2013–2015. Contraception. 2018;98(3):188-92. [40] Knaus H. Eine neue methods zur bestimmung des ovulationstermines. Zentralbl F Gynak. 1929;53:2193. [41] Ogino K. Histological studies on corpora lutea, period of ovulation, relation between corpora lutea and cyclic changes in uterine mucous membrane, and period of fertilization. Japanese Medical World. 1928;8:147. [42] Festin MP, Kiarie J, Solo J, Spieler J, Malarcher S, Van Look PF, et al. Moving towards the goals of FP2020 - classifying contraceptives. Contraception. 2016;94(4):289-94. [43] Malarcher S, Spieler J, Fabic MS, Jordan S, Starbird EH, Kenon C. Fertility Awareness Methods: Distinctive Modern Contraceptives. Glob Health Sci Pract. 2016;4(1):13-5. [44] Starling MS, Kandel Z, Haile L, Simmons RG. User profile and preferences in fertility apps for preventing pregnancy: an exploratory pilot study. Mhealth. 2018;4:21.

27

[45] Hampton K, Mazza D. Fertility-awareness knowledge, attitudes and practices of women attending general practice. Aust Fam Physician. 2015;44(11):840-5. [46] ACOG Committee on Adolescent Health Care. ACOG Committee Opinion No. 349, November 2006: Menstruation in girls and adolescents: using the menstrual cycle as a vital sign. Obstetrics and gynecology. 2006;108(5):1323. [47] Sinai I, Lundgren R, Arévalo M, Jennings V. Fertility awareness-based methods of family planning: predictors of correct use. Int Fam Plan Perspect. 2006;32(2):94-100. [48] Choi J, Chan S, Wiebe E. Natural family planning: physicians' knowledge, attitudes, and practice. J Obstet Gynaecol Can. 2010;32(7):673-8. [49] Stanford JB, Thurman PB, Lemaire JC. Physicians' knowledge and practices regarding natural family planning. Obstet Gynecol. 1999;94(5 Pt 1):672-8. [50] Urrutia RP, Polis CB. Fertility awareness based methods for pregnancy prevention. BMJ. 2019;366:l4245. [51] Dehlendorf C, Krajewski C, Borrero S. Contraceptive counseling: best practices to ensure quality communication and enable effective contraceptive use. Clin Obstet Gynecol. 2014;57(4):659-73. [52] Duane M, Contreras A, Jensen ET, White A. The Performance of Fertility Awarenessbased Method Apps Marketed to Avoid Pregnancy. J Am Board Fam Med. 2016;29(4):50811. [53] Ross J, Hardee K. Access to contraceptive methods and prevalence of use. J Biosoc Sci. 2013;45(6):761-78. [54] Gainer E, Kenfack B, Mboudou E, Doh AS, Bouyer J. Menstrual bleeding patterns following levonorgestrel emergency contraception. Contraception. 2006;74(2):118-24. [55] Kavanaugh ML, Jerman J. Contraceptive method use in the United States: trends and characteristics between 2008, 2012 and 2014. Contraception. 2018;97(1):14-21.

28

[56] Pedro J, Brandão T, Schmidt L, Costa ME, Martins MV. What do people know about fertility? A systematic review on fertility awareness and its associated factors. Ups J Med Sci. 2018;123(2):71-81. [57] Hatcher RA. Contraceptive Technology 21st ed. New York, NY: Ayer Company Publishers, Inc.; 2018.

FIGURE 1 LEGEND This figure provides illustrations demonstrating the application for each of the fertility awareness-based methods outlined in the article. Images are shared with permission. FIGURE 2 LEGEND This figure provides an overview of perfect- and typical-use pregnancy rates of all userinitiated methods of contraception. Fertility awareness-based methods are shown in red, with the darker color demonstrating perfect-use pregnancy rates, while the lighter color shows typical-use pregnancy rates. Other methods are shown in blue, with darker blue demonstrating perfect-use pregnancy rates and the lighter blue showing typical-use pregnancy rates.

29

Table 1. Fertility awarenessawareness-based methods overview Efficacy1

Method Name

Learning Period

Restrictions for Users

Physiologic Signs or Symptoms

Tools Needed

Provider Engagement

Support Resources

Single Sign/Symptom Methods

*Billings Ovulation Method

Perfect Use

Typical Use

3

23

None - Can Begin Use Immediately

2

Dot

Two to Four Weeks

1

5.8 Conservative Estimates in Initial Cycles None - Can Begin Use Immediately

Natural Cycles

1

8.3

None

Cervical Fluid

Paper or Electronic Menstrual Charts

Cycle Lengths Between 20-40 Days

Menstrual Cycle Start Dates

iOS or Android App

None

Basal Body Temperature

Conservative Estimates in Initial Cycles Standard Days Method (Cycle Beads)

5

12

Two Day Method

4

14

Perfect Use

Typical Use

Basal Body Thermometer iOS or Android App

None - Can Begin Immediately

Cycle Lengths Between 26-32 Days

Menstrual Cycle Start Dates

Cyclebeads; or Cycle Beads App (iOS or Android); or Paper Calendar

None - Can Begin Immediately

None

Cervical Fluid

iPhone App;

Referral

Certified Instructor, eBooks, Charting Apps; Website

Demo App Use

In-App Tutorial; Web-Based Overview

Demo App Use

In-App Tutorial; Web-Based Overview

Demo Beads, App, or Calendar, Depending on Interest In-Clinic Training; or Demo App Use

Provider Counseling Job Aid Fact Sheet; Website

In-App Tutorial; Website

Multiple Signs/Symptoms Methods

*Marquette Method Cervical Fluid and Urinary LH Test3

Symptothermal Method

*

NA

3

0.4

6.8

2

Can Begin Upon Completion of Training

3 Cycles to Use as a Contraceptive Method

Cycle Lengths Between 22-42 Days

Cervical Fluid Urinary Hormone Test *Optional - Basal Body Temperature Cervical Fluid Basal Body Temperature

None *Optional - Cervical Positioning Urinary Hormone Test

Clearblue Fertility Monitor and Urinary Strips Referral

Certified Instructor, Charting App, Website

Referral

Certified Instructor, Ebook, Workbook, Book, In-App Tutorials for Charting Apps (e.g., Kindara, Lily, Ovuview, Ladycycle)

Paper or Electronic Fertility Chart

Basal Body Thermometer Paper or Electronic Fertility Chart

Support resources for these methods utilize natural family planning guidelines for abstinence during the fertile window. As reported in Contraceptive Technology, 2018; methods not included in Contraceptive Technology are cited separately and include Dot and the Marquette Method. Fewer studies have been conducted on various FABM methods than on other methods of contraception; as more research is done on FABM use, efficacy rates may adjust accordingly 2 Jennings, et al. 2019 3 Fehring, et al. 2017; Perfect use rates exist for other variants (cervical fluid only/monitor only) of the Marquette Method. 1

% of women in the United States experiencing an unintended pregnancy within the first year of use

METHOD

1

FABM Method

FABM Method

Perfect Use

Typical Use

Other Methods

Other Methods

Perfect Use

Typical Use

0%

20%

40%

60%

80%

100%

0%

10%

20%

30%

40%

50%

No Method Perfect Use: 85 Typical Use: 85

Billings Ovulation Method Perfect Use: 3 Typical Use: 23

Combined Oral Contraceptive Pill Perfect Use: 0.3 Typical Use: 7

Condom (external) Perfect Use: 2 Typical Use: 13

Condom (internal) Perfect Use: 5 Typical Use: 21

Copper IUD (ParaGard) Perfect Use: 0.6 Typical Use: 0.8

Depo-Provera Perfect Use: 0.2 Typical Use: 4

Diaphragm Perfect Use: 16 Typical Use: 17

Dot

2

Perfect Use: 1 Typical Use: 5.8

Evra Patch Perfect Use: 0.3 Typical Use: 7

19.5 mg LNG IUD (Kyleena) Perfect Use: 0.2 Typical Use: 0.2

52 mg LNG IUD (Liletta/Mirena) Perfect Use: 0.1 Typical Use: 0.1

Marquette Method

3

Perfect Use: NA Typical Use: 6.8

Natural Cycles App Perfect Use: 1 Typical Use: 8.3

Nexplanon Perfect Use: 0.1 Typical Use: 0.1

NuvaRing

Perfect Use: 0.3 Typical Use: 7

Progestin-Only Contraceptive Pill Perfect Use: 0.3 Typical Use: 7

13.5mg LNG IUD (Skyla) Perfect Use: 0.3 Typical Use: 0.4

Spermicides Perfect Use: 16 Typical Use: 21

Sponge Perfect Use: 12 Typical Use: 17

Standard Days Method Perfect Use: 5 Typical Use: 12

Symptothermal Method Perfect Use: 0.4 Typical Use: 2

Tubal Occlusion Perfect Use: 0.5 Typical Use: 0.5

TwoDay Method Perfect Use: 4 Typical Use: 14

Vasectomy

Perfect Use: 0.1 Typical Use: 0.15

Withdrawal Perfect Use: 4 Typical Use: 20

1 As reported in Contraceptive Technology, 2018; methods not included in CT are cited separately and include Dot and the Marquette Method. Fewer studies have been conducted on various FABM methods than on other methods of contraception; as more research is done on FABM use, efficacy rates may adjust accordingly 2 Jennings, 2019 (13-cycle efficacy paper) 3 Fehring, et al. 2017

HIGHLIGHTS • Fertility awareness-based methods (FABMs) are contraceptive methods where people use personal physiological data to determine their daily fertility and then make behavioral decisions around sexual activity on fertile days.

• There are several different FABMs; each method collects different physiologic signs and symptoms, each has separate rules for use, and each has different perfect- and typical-use efficacy pregnancy rates.

• Many fertility apps and fertility devices have recently been developed, yet few of these apps or technologies have been subject to rigorous research around their contraceptive effectiveness.