Increased access to care through creation of private foundations: the Chicago experience

Increased access to care through creation of private foundations: the Chicago experience

in follicular fluid from small antral human follicles. J Clin Endocrinol Metab, 93 (2008), pp. 2344-2349. Supported by: Entirely internal (CRMI fundin...

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in follicular fluid from small antral human follicles. J Clin Endocrinol Metab, 93 (2008), pp. 2344-2349. Supported by: Entirely internal (CRMI funding). O-6 Monday, October 17, 2016 12:30 PM RANDOMIZED CONTROLLED TRIAL OF LOW (5%) VS. ULTRALOW (2%) OXYGEN TENSION FOR IN VITRO DEVELOPMENT OF HUMAN EMBRYOS. D. J. Kaser,a B. Bogale,a V. Sarda,b L. V. Farland,a,c C. Racowsky.a aDept of Obstetrics & Gynecology, Brigham & Women’s Hospital, Harvard Medical School, Boston, MA; bBoston Children’s Hospital, Boston, MA; cDept of Epidemiology, Harvard Chan School, Boston, MA. OBJECTIVE: As the human embryo traverses the utero-tubal junction late on day 3, it is exposed to a step-down in O2 tension from 5-7% in the Fallopian tube to 2% in the uterus. The question therefore arises whether the IVF culture system should mimic this progressively hypoxic environment. The present study tested the hypothesis that sequential exposure first to 5% O2 from days 1 to 3, and then to 2% O2 from days 3 to 5, improves blastocyst yield and quality compared to continuous exposure to 5% O2. DESIGN: Randomized controlled trial of sibling embryos. MATERIALS AND METHODS: Donated sibling embryos (n¼203), blocked on pronuclei (PN) status (2PN vs. 3PN), were randomized to either 5% O2 from days 1 to 5 (5-5% Group; n¼102) or 5% O2 from days 1 to 3 and then 2% O2 to day 5 (5-2% Group; n¼101). Stage and grade were assessed on day 5 by embryologists blinded to Group; usable blastocysts were those meeting freezing criteria. Cell counts of embryos from 3PNs were obtained by nuclear staining; 2PNs were used for ongoing gene expression studies. Odds ratios (OR) with 95% CI were calculated using generalized estimating equations to account for correlations among embryos from the same woman, adjusted a priori for oocyte age and source (autologous vs. donor), IVF vs. ICSI, PN number, fresh vs. thawed embryo and % goodquality embryo (GQE) on day 3. Differences in mean cell number and proportions of developmental stages were analyzed by independent t-tests and chi-square, respectively. Based on data comparing atmospheric (20%) vs. 5% O2, this study was powered to detect a 16.5% difference in day 5 GQE (a¼0.05, b¼0.80).1 RESULTS: The percentage of day 3 GQEs did not differ between groups (5-5% O2 vs. 5-2% O2: 28.4% vs. 30.7%; OR 1.14 [CI¼0.74-1.76]; P¼0.76). Embryos in the 5-2% Group were less likely to arrest at cleavage and more likely to blastulate (Table). Notably, in the 5-2% Group, there was a two-fold increase in the odds of conversion to a usable blastocyst (OR 2.30 [CI¼1.164.56]; P¼0.02), yet blastocysts had fewer cells (Table). CONCLUSIONS: These findings support our hypothesis that blastocyst yield and quality may be superior when O2 tension is reduced from 5% to 2% on day 3, thereby recapitulating the O2 environment in vivo. Further studies are warranted to confirm whether these preliminary findings translate into a paradigm shift for extended culture in clinical IVF, and to investigate the significance of lower cell counts in blastocysts cultured in 2% O2, particularly as related to the ‘quiet hypothesis’ for embryo metabolism.2 References: Table. Stage and cell count of embryos cultured from days 3 to 5 in low (5%) vs. ultralow (2%) O2

Stage per cleaved embryo n (%) Cleavage arrest Morula Early blastocyst Full, expanded or hatching blastocyst Any blastocyst Usable blastocyst Mean cell count + SD Early blastocyst Full, expanded or hatching blastocyst Any blastocyst

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ASRM Abstracts

5-5% O2 Group

5-2% O2 Group

OR (95% CI)

52/89 (58.4) 17/89 (19.1) 11/89 (12.4) 9/89 (10.1)

34/87 (39.1) 18/87 (20.7) 23/87 (26.4) 12/87 (13.8)

0.38 (0.18, 0.80) 1.09 (0.47, 2.53) 2.59 (1.06, 6.32) 1.43 (0.56, 3.64)

20/89 (22.5) 35/87 (40.2) 2.55 (1.27, 5.12) 19/89 (21.3) 32/87 (36.8) 2.30 (1.16, 4.56) 5-5% O2 Group

5-2% O2 Group

P-value

44.4 + 2.1 83.4 + 15.9

35.5 + 10.9 62.0 + 14.5

0.01 0.04

60.7 + 22.3

43.8 + 17.3

0.01

1. Kovacic B, Vlaisavljevic V. Influence of atmospheric versus reduced O2 concentration on development of human blastocysts in vitro: a prospective study on sibling oocytes. Reprod Biomed Online 2008;17:229-36. 2. Leese HJ. Quiet please, do not disturb: a hypothesis of embryo metabolism and viability. Bioessays 2002;24:845-9. Supported by: The Foundation for Embryonic Competence. ACCESS TO CARE 1 O-7 Monday, October 17, 2016 11:15 AM EMPLOYER ENGAGEMENT AND EDUCATION INCREASES ACCESS TO CARE AND ESET UTILIZATION. G. Harton,a M. Larman,b K. Ajmani,c J. R. Tomasino,d G. Bartasi.e aProgyny, New York, NY; bProgyny, San Francisco, CA; cProgyny, Inc., New York, NY; d Progyny; eProgyny, Inc., 47th Floor, NY. OBJECTIVE: Demonstrate that educating employers on ART practices, clinical outcomes and technology advances can increase access to care and utilization of ART by employees. Furthermore, will adoption of coverage by informed employers increase the use of elective single embryo transfer (eSET) and significantly reduce multiple gestations as a result of IVF treatment? DESIGN: A retrospective analysis with historical company and national data. MATERIALS AND METHODS: The funded ART benefit offered by a number of large, self insured employers was examined and analyzed to assess the associated expense to the employer for employees utilizing ART. The employers were informed and educated on innovations within the ART field. Beginning in January 2016 employees in two companies began utilizing a new fully funded ART benefit that included embryo selection and eSET. Historical company data on the cost of high order multiples from ART treatment in 2014 was compared to expected data based on eSET in the fully funded program. In addition, the percentage of employees utilizing the benefit was compared to national averages in multiple states in the U.S. RESULTS: In Q1 2016, 299 ART treatments were initiated (248 IVF and 51 IUI) for a predicted annual utilization rate of approximately 1%. When compared to utilization rates nationally and in the home state of the employers using 2013 SART data (0.25 %), the utilization thus far is four times higher. Nationally, in 2013, eSET was performed in 23.6 % of patients of all ages. Thus far in Q1 2016, with increasing employee awareness, the monthly percentage of eSET cycles reached 80% with an overall pregnancy rate of 56.9 % (FHB+). With continued education on the advantages of eSET we expect the percentage of cycles with transfer of one embryo to continue to increase. At the end of Q1 there were no multiple gestations reported in this data. CONCLUSIONS: NThe utilization rate for the two companies is 4 times higher than the national average and double the utilization rates seen in states with an ART mandate (0.48%). This data clearly shows that an employer offering a fertility benefit will increase utilization of IVF in the U.S. In SART 2013 data the average number of embryos transferred was 1.8 in women < 35. Given that the medical costs associated with multiple gestations are at least 5-20 times higher than singletons, the use of eSET to increase the percentage of singleton births will result in a predicted savings of approximately $4 Million/employer based on our analysis of claims data and the Truven Health Analytics database. By engaging and educating employers with regards to the need for ART coverage and the medical and financial burdens associated with multiple gestations, it is anticipated that more than the current 25% of employers, which provide an ART benefit, will fund comprehensive coverage for IVF treatments in the coming years. O-8 Monday, October 17, 2016 11:30 AM INCREASED ACCESS TO CARE THROUGH CREATION OF PRIVATE FOUNDATIONS: THE CHICAGO A. Borowiecki,b R. Morris,c EXPERIENCE. E. C. Feinberg,a d e fa L. Rinehart, N. Desai, J. E. Hirshfeld-Cytron. Fertility Centers of Illinois, Highland Park, IL; bKevin J. Lederer Life Foundation, Highland Park, IL; c IVF1, Naperville, IL; dLegal Care Consulting, Inc., Burr Ridge, IL; eBallard, Desai, & Miller, Chicago, IL; fFertility Centers of Illinois, Chicago, IL. OBJECTIVE: Access to infertility care is a worldwide concern. Only 24% of infertile couples in the United States are able to access the medical care

Vol. 106, No. 3, Supplement, September 2016

needed to achieve pregnancy. ASRM held a summit meeting in Washington, D.C. in September 2015 to address this unmet need. The summit resulted in several strategies to broaden access to care and a task force was created to carry out actionable strategies. One such actionable strategy was the development of private foundations to which practitioners, industry or grateful patients could donate resources and/or money. DESIGN: Observational study. MATERIALS AND METHODS: The Kevin J. Lederer Life Foundation was created to promote health and alleviate the mental and physical distress of those diagnosed with infertility through education and financial assistance. The Life Foundation is a collaborative effort among Chicagoland REI practices to broaden access to fertility care in Illinois. RESULTS: There are 19 clinics that provide ART services in Illinois. Nine of 19 (47%) participated in the Life Foundation, either by donation of medical service or volunteer service on the Foundation Board. The Foundation partnered with fertility clinics for provision of unreimbursed care and 11 IVF cycles were donated by 7 clinics. Community partners such as reproductive attorneys and third party agencies were solicited for service donations while industry partners and grateful patients were solicited for financial support. 2015 was the first fully operational year of the Life Foundation. A 5K race and a bowling fundraiser was held to raise money to cover foundation operating costs and for financial grants. All Foundation members volunteer time, there is currently no paid support staff. A medical advisory board comprised of 4 board-certified REIs selected grant recipients based on financial need and medical prognosis. Eighty-five patients applied for grants and thirteen grants (15.3%) were awarded. Grants were a combination of donated IVF cycles and financial grants to defray the costs of associated with egg donation, gestational carrier use and adoption. 3 live births and 2 pregnancies have subsequently ensued. The Foundation also held educational events covering topics such as oocyte vitrification, adoption, male factor infertility and the psychological impact of fertility care. The Foundation newsletter has 1300 subscribers. CONCLUSIONS: There remains a large unmet need within the United States for fertility care. Creation of private foundations is one mechanism to immediately increase access to care. Success of these foundations is dependent on widespread community engagement. Collaboration with organizations such as ASRM would be beneficial to streamline processes. Greater financial support is needed to help sustain growth and viability. O-9 Monday, October 17, 2016 11:45 AM INFERTILITY & FAMILY-BUILDING PRIORITIES. E. A. Duthie,a A. Cooper,b J. B. Davis,c J. Sandlow,a K. D. Schoyer,a E. Y. Strawn,a K. E. Flynn.a aMedical College of Wisconsin, Milwaukee, WI; bDuke University, Durham, NC; cMichigan State University, Grand Rapids, MI. OBJECTIVE: To describe the family-building priorities most important to patients and partners seeking care from a reproductive endocrinology and infertility specialist (REI) over time. DESIGN: Longitudinal prospective cohort study of 85 infertility patients (pregnancy candidates, PCs) and 62 supporting partners (SPs) %1 week before a first consultation with a REI and 12 months later. MATERIALS AND METHODS: At both time points, respondents separately completed a novel Family-Building Priorities Ranking Tool which tasked them with prioritizing a list of 10 factors associated with different

family-building paths (wording in Table). We describe the percentage of participants who ranked each factor among their highest (top three) priorities pre-consult and at 12 months and the agreement between partners within couples. We examined differences in priorities by role using chi-squared tests and changes in top priorities from pre-consult to 12 months using McNemar’s test (both at a¼0.05). RESULTS: We found significant differences between the top three priorities of PCs and SPs at both time points (Table). Other factors found general consensus: a majority of respondents in both roles highly prioritized maintaining their relationship with their partner, and %5% of respondents prioritized the ability to maintain privacy about their family-building methods. For PCs, more than half of those who prioritized being pregnant and giving birth pre-consult no longer included this factor among their highest priorities by 12 months post-consult (p¼0.04). There were no significant changes over time in highest priority rankings among SPs. At both time points, in >70% of couples, both members had in common 1 or 2 of their highest priorities; very few shared all 3 highest priorities (7% pre-consult; 4% at 12 months). CONCLUSIONS: While there was general agreement among PCs and SPs about the importance of maintaining their relationships with their partners throughout their family-building process, consensus was lacking when it comes to the relative importance of other family-building priorities. REIs who provide support to patients and their partners in assessing the pros and cons of available family-building paths should be aware that becoming a parent may not be the highest priority for many of their patients. Family building is frequently a partnered activity, and the clinical discussions and treatment decisions that shape it should involve both prospective parents and incorporate awareness of the potential for discrepant priorities. Supported by: Funding for this study came from R21HD071332 from the National Institute of Child Health and Human Development. Dr. Duthie received additional support from a National Research Service Award T32 HP10030. REDCap was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through 8UL1TR000055.

O-10 Monday, October 17, 2016 12:00 PM LETROZOLE + GONADOTROPIN PROTOCOL FOR SUPEROVULATION INDUCTION/INSEMINATION CYCLES: A NOVEL APPROACH TO INCREASE ACCESS OF CARE AND VALIDATED BY SUPPLY & DEMAND CURVE ANALYSIS. M. X. Ransom. OB/GYN, Quillen College of Medicine, Johnson City, TN. OBJECTIVE: To identify the benefits of offering a letrozole/FSH (folliclestimulating hormone) hybrid protocol to clomiphene citrate-alone and letrozole-alone failures for superovulation induction insemination + intrauterine (SOI/IUI) cycles prior to considering an FSH-alone protocol, and thereby increase access to care among an infertility population. DESIGN: Patients attending a University infertility practice in Eastern Appalachia were recognized who had failed to conceive by clomiphene citrate and letrozole-alone cycles and were unable to financially consider either a gonadotropin-only/IUI or IVF (in vitro fertilization) cycle. Those patients were offered a letrozole/FSH combined cycle as an affordable alternative to abandonment of treatment.

Pre-Consult

12 Months*

Percent of respondents ranking each factor among top 3 priorities

Pregnancy Supporting Pregnancy Supporting Candidates Partners Candidates Partners (n ¼ 82) (n ¼ 61) (n ¼ 39) (n ¼ 24) That I become a parent one way or another 52% 38% 59% 33% That I/my partner get(s) to be the person who is pregnant with and gives birth to my child 42% 36% 23% 38% That my child has [pregnancy candidate’s] genes 22% 30% 31% 33% That my child has [supporting partner’s] genes 20% 39% 26% 50% That I have a child in the next year or two 55% 23% 39% 25% Cost 24% 16% 13% 21% That I can build my family in a way that doesn’t make it obvious to others that we had trouble 1% 0% 5% 0% That I get to parent my child from birth 20% 16% 13% 21% That I maintain a close and satisfying relationship with my partner 62% 79% 74% 58% That I avoid side effects from medical treatments 2% 20% 10% 13%

Bold: significant difference by role; *Includes only respondents who are not pregnant/parenting

FERTILITY & STERILITYÒ

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