Appraisal of gamete intrafallopian transfer

ELSEVIER

European Journal of Obstetrics & Gynecology and Reproductive Biology 58 (1995) 59-65

GYNECOU

Appraisal of gamete intrafallopian transfer Dror Meirow, Joseph G. Schenker Department of Obstetrics and Gynecology, Hadassah University Hospital, Ein-Kerem, Jerusalem, Israel Accepted 9 August 1994

Abstract Objective: To collect results of gamete intrafallopian transfer on a large scale in order to compare treatment indications, results, and factors which influence the success rates; to evaluate whether gamete intrafallopian transfer is well-established and what the real place of this procedure is among other assisted reproduction techniques. Design: Data relating to gamete intrafallopian transfer were collected from World Reports, national registries of different countries and meta-analysis of medical publications during the years 1986-1991. Subject: Official registries reported 47 200 treatment cycles and 18 759 treatment cycles were analysed from ten medical publications. Results." The procedure accounts for 13.5% of all assisted reproduction techniques but its popularity varies significantly among countries. The same indications for gamete intrafallopian transfer are followed by all countries, but great differences exist with regard to the proportional share of each etiology. Also, the share has changed considerably over the years. Treatment outcome: 10 667 clinical pregnancies were reported which represent 24% of treatment cycles and 29% of ovum pick-up. The live birth rate was 23.3%; abortion rate, 22%; and ectopic pregnancy rate, 5.5%. The stillbirth rate was 2.3% and the malformation rate was 2.8%, not confined to specific organs or systems. There were 19.5% twins, 4.6% triplets and 0.3% quadruplets or more. The number of transferred oocytes influenced pregnancy rates: 28% for transfer of four oocytes and only 10% following transfer of one oocyte. The cause of infertility might influence the results and the poorest results are obtained for male factor infertility. In most cases correlation of success rates reported by leading units through medical publications closely resembles the overall national registries results. Indications for this treatment were broadened over the years, but its role among other assisted reproduction technologies is not agreed upon, especially for male factor and unexplained infertility. Conclusions: Gamete intrafallopian transfer carries an overall higher pregnancy rate than in vitro fertilization. Quality control by professional or public associations should be established and more research employed over indications for treatment and results in order to establish when GIFT is the treatment of choice and when other modes of treatment should be preferred. Keywords: GIFT indications; G I F T outcome; World results

1. Introduction G a m e t e intrafallopian transfer ( G I F T ) has been established as a m e t h o d o f treatment for h u m a n infertility since 1986. The G I F T technique involves the recovery o f ova by l a p a r o s c o p y and transfer o f gametes into the fallopian tube(s) during the same operation. This procedure gave further therapeutic o p t i o n to in vitro fertilization with e m b r y o transfer ( I V F - E T ) for infertile women with at least one patent tube. A l t h o u g h G I F T is com* Corresponding author, Department of Obstetrics and Gynecology, Hadassah University Hospital, POB 12 000, Jerusalem 91120, Israel.

m o n practice in m a n y countries, available d a t a concerning G I F T are incomplete [1]. Questions such as w h a t is the percentage o f G I F T procedures a m o n g s t all assisted reproduction techniques, what are the indications for patient selection, w h a t are the success rates o f the G I F T procedure, and w h a t factors influence these rates, m a y reveal the actual place o f G I F T today. Due to controversy in the literature a n d lack o f information, the place o f G I F T p r o c e d u r e has not been established so far. The p u r p o s e o f this w o r k is to collect results o f G I F T procedures on a large scale and to c o m p a r e treatment indications, results, and factors which influence the suc-

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D. Meirow, J.G. Schenker / European Journal of Obstetrics & Gynecology and Reproductive Biology 58 (1995) 59-65

cess rates, and, above all, to evaluate whether GIFT is well established and what the real place of this procedure is in the armamentarium of assisted reproduction techniques today. 2. Materials and methods

Information was obtained from published registries and official publications which have reported GIFT procedures and pregnancy outcomes during the years 1986-1991. Results were collected from world collaborative reports in 1989 and 1991 [2,3] and the official registries of Australia and New Zealand (NZ), France (F), Japan (J), South Africa (SA), the UK, and the USA [4-17]. In addition, through a literature review we carried out meta-analysis of publications which report GIFT results. Only the GIFT results were evaluated; other procedures such as zygote intrafallopian transfer (ZIFT) and tubal embryo transfer (TET) were excluded. Parameters concerning GIFT procedures and results included treatment cycles, indications for treatment, clinical pregnancies rates, ectopic pregnancies, abortion and stillbirth rates; liveborn rates, multiple pregnancies, and malformation rates. Success rates were compared with transferred oocyte number and evaluated separately for causes of infertility. Data obtained from medical journals were compared with compatible data from official publications (of the same countries and during the same year) in order to evaluate the similarities between published results, which represent selected GIFT units, and national results.

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Fig. 1. GIFT rate among all assisted reproduction techniques during the years 1986-1991: global results and national results.

plained infertility share and the endometriosis share dropped from 31.5 to 26% and 18.3% to 14.2%, respectively. 3.1. Treatment outcome Clinical pregnancy rates. A total of 10 667 clinical

pregnancies were reported out of 43 966 treatment cycles (24%) and 8634 clinical pregnancies were the result of 29 628 ovum pick-ups (OPU; 29%). The outcomes of clinical pregnancies were partially reported; a few centers reported only partial results and other units did not report their pregnancies outcome at all.

3. Results

During the years 1986-1991, 47 200 treatment cycles were reported by registries and official publications [2-18]. Ten large publications reported 18 750 treatment cycles between the years 1986 and 1993 [1,19-27]. Worldwide, the GIFT procedure accounts for 13.5% of all assisted reproduction techniques, but, as Fig. 1 indicates, there are great variations omong countries. GIFT procedure is uncommon in Israel and France (only 0.5% and 4%, respectively of all assisted reproduction techniques). In contrast, it is commonly practiced in NZ and SA (35% and 71%, respectively). Infertility causes which indicate GIFT treatment are the same in all countries, but great differences exist with regard to the proportional share of each etiology (Fig. 2). Moreover, that share has changed considerably during the investigated years. In NZ [4-8] only 11.7% of GIFT procedures were performed due to male factor indication in 1986, while in 1989, it accounted for 25% of GIFT procedures. During the same time the unex-

~////~

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40 30 20 10

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r VFqU.K. [7~N.Z [ ] F [ ] J [~ U.S. Fig. 2. The distribution of each cause of infertility from all GIFT procedures as reported by several countries. Mechanical factor (mechan.), male factor, endometriosis (endomet.), unexplained infertility (unexp.) and other causes of treatment.

D. Meirow, J.G. Schenker I European Journal of Obstetrics & Gynecology and Reproductive Biology 58 (1995) 59-65

Live births. A total of 6341 babies were born following 27 114 OPU (23.3%); 5625 live born babies were the outcome of 7751 clinical pregnancies (72.5%). A total of 180 ectopic pregnancies occurred following 12 754 OPU (1.4%), which represent 5.5% of clinical pregnancies. Abortion rates. Abortions were reported for only 7239 clinical pregnancies. These pregnancies resulted in 1617 abortions which represent 22%. Stillbirth rates. Eighty-two stillbirths were the results of 4260 clinical pregnancies (1.9%). All pregnancy outcomes (presented as the percentage of all clinical pregnancies) are summarized in Table 1. A total of 105 malformed fetuses were reported in 3773 pregnancies (2.8%). The variety of malformations was not confined to specific organs or systems. Multiple pregnancy rates were as follows: 75.5% of clinical pregnancies were singleton, 19.5% twins, 4.6% triplets, and 0.3% were quadruplets or more. The correlation between pregnancy rates and the number of transferred oocytes was evaluated. As the number of transferred oocytes increased (up to four), pregnancy rates increased as well: following the transfer of four oocytes, the pregnancy rate was 28%, 24% following the transfer of three oocytes, and only 10% following the transfer of one oocyte (Fig. 3). Transfer of more than five oocytes failed to improve the pregnancy rates, but on the other hand, multiple pregnancy rates increased to 25% of pregnancies [27] or even 31% of pregnancies [24]. In 5050 cycles, the pregnancy rate following GIFT was evaluated for each cause of infertility separately. The following indications were evaluated: unexplained infertility, endometriosis, tubal factor, and male factor infertility. Treatment success rates are reported as clinical pregnancy rates and are presented for each indication in Fig. 4. Seven medical publications were compared with official registries, and success rates were measured as clinical pregnancy rates (Fig. 5). The results show that most publications closely resembled national registries when correlation was assessed for the same country and during the same years.

61

PREGNANCY RATE (%)

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Fig. 3. Pregnancy rates according to the number of transferred oocytes.

4. Discussion Our data indicate that G I F T has been practised in over 33 countries since the earliest attempts in 1984 [28] and accounts for 13.5% of all assisted reproduction techniques. In recent years, most countries began concerning themselves about registration of their assisted reproduction activities in order to increase the peer control of these methods. However, proper evaluation still faces several difficulties - - precise data on the clinical outcome of all assisted reproduction methods in general are not available, and their absence is particularly felt for

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10Table 1 Pregnancy outcome following GIFT

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Fig. 4. Pregaancy rate for endometriosis, tubal factor, male factor and unexplained infertility as reported by Wong et al. [20], Craft and Brindsen [21], Yovich and Matson [22], Murdoch et al. [25], and official registries of France 1987 [9], 1988 [101.

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P R E G N A N C Y RATE (%) 3 5 :: 30 z

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~ Wong Younger Nelson Craft 1 Craft 2 Heines Yovich il~Publication [ ] S l a t e record

Fig. 5. Comparison between pregnancy rates for GIFT procedures as reported in medical publications and official publications, respectively. Results were compared for the same countries and during the same years. Data were evaluated for the following publications: Wong et al. [20], Younger [19], Nelson et al. [27], Craft and Brindsen [21], Craft 124], Haines and O'Shea [261, Yovich a n d Matson [22].

G I F T [1]. Not all countries have national registries. Information is provided voluntarily and is, therefore, probably incomplete, since the missing data might relate to centers that obtained poor results. Moreover, a major difficulty that was readily noticed during data collection and interpretation was that the format for data collection varies from one center to another, from one country to another, and even in the same country from one year to another. According to the World Health Organization Committee [29] representative criteria for success were not available in all the published data that was analysed. Moreover, the number of women who were treated, their age, and the cost effectiveness of the procedure are not available in most reports. When the actual data from the national registries were carefully studied, great differences between units, even in the same country and during the same year, were present [4-8,12-16]. These differences may be attributed to the activity range of the unit, experience of the staff, and research efforts. On the other hand, medical publications show data from leading units which are usually large and experienced. Our results (Fig. 5) show that in most cases the success rates reported by leading units through medical publications closely resemble the overall nationally-reported success rates. The contribution of those large centers to the overall national success rate is significant and differences between units from the same country probably represent differences in performance (usually with poorer results) of smaller units that do not publish their data. Therefore, G I F T and probably all assisted reproduction activity should be practised in larger centers; merging small units into large centers would be preferable. When we compared the share of G I F T practice from

all assisted reproduction techniques in different cou,ltries, it was readily recognized that the popularity of this procedure varies between countries (Fig. 1). The reason for differences such as 70% in South Africa and 35% in Australia and New Zealand on the one hand and 0.5% in Israel and 4% in France on the other hand, are not clearly understood. Such differences may be partially related to religious considerations. G I F T is more favorably adopted by religious authorities in general and especially by the Roman Catholic Church since it interferes less with the process of procreation than IVFET and therefore may be more consistent with the Church's moral guidelines [30,31]. Another reason accounting for increased G I F T practice might be at centers where complete IVF laboratory and scientific personnel are unavailable, and treatment is, therefore, deliberately shifted toward GIFT. Today this argument is seldom claimed and should not be considered. In 1988 the American Fertility Society established standards for GIFT. A gamete laboratory with experienced personnel is one minimal criteria [32]. Today GIFT should not be practiced in units where no IVF-ET facilities are available for back-up. The original indication for IVF-ET was for patients with no fallopian tubes or whose fallopian tubes have been very severely damaged. In the following years indications for IVF-ET increased; today the general criteria for IVF-ET and G I F T are identical, with the prerequisite of at least one patent fallopian tube in the case of GIFT. The group of G I F T patients is heterogenous and today the procedure may offer solutions for several causes of infertility [10,18,20-22,24,27,33-37]. As Fig. 2 indicates, different countries use different criteria for patient selection. For example, male factor infertility accounted for 47% of G I F T procedures in Japan, while in the UK it accounted for 18.8% of G I F T procedures during the same year. G I F T treatment for tubal disease accounted for only 4.5% of procedures in NZ, but for 16.6% in UK during the same year. On the other hand, the share of endometriosis and unexplained infertility was similar in all countries whose data were reviewed.

4.1. Indications for GIFT What are the indications for G I F T treatment today and which infertility categories are best treated by other means? Several publications have suggested that male factor infertility is successfully treated by means of G I F T [3,11,18,33,36,37] and indeed its relative share has increased in the last few years. There is an obvious obstacle when we evaluate G I F T results for male factor infertility. In most publications, seminal fluids' properties are not presented, so this group is, therefore, extremely heterogeneous. Nelson et al. [27] reported that only the motility in the specimen used for G I F T showed

D. Meirow, J.G. Schenker/European Journal of Obstetrics & Gynecology and Reproductive Biology 58 (1995) 59-65

a statistically significant association with the initiation of pregnancy. Other variables such as semen volume, concentration, morphology, and hamster egg penetration test had no significant prognostic value. Matson et al. [38] showed that no pregnancies were recorded when 105 sperm were placed in the tube. Appraisal of G I F T for male factor infertility must include semen properties in order to evaluate the effectiveness of this method. Moreover, when a woman fails to conceive following G I F T treatment, semen potency (the capability to fertilize oocytes) is not established. On the other hand, today other procedures such as ZIFT, PROST, TET and IVF-ET do establish semen potency. Moreover, IVF-ET offers solutions in cases of severe male factor infertility when poor fertilization is anticipated. With micromanipulation techniques fertilization may occur in cases where the G I F T procedure cannot offer a solution. It therefore seems that IVF-ET with the option of micromanipulation or TET procedure [20] which may prove sperm potency are better choices for male factor infertility [23]. More studies and detailed registries are needed in order to establish the place of G I F T treatment in male factor infertility. In several reports, G I F T is commonly practiced in couples with unexplained infertility [4-18,39,40]. Murdoch et al. [25] showed that fecundity following G I F T was much higher than after ovarian stimulation and intrauterine insemination (IUI; 0.12 and 0.018, respectively). On the other hand, several other reports suggested that IUI after ovarian hyperstimulation may have similar success rates [41-43]. These studies demonstrate that the success rates of six or seven menotropin treatment cycles combined with IUI for unexplained infertility rose steadily up to 45% in the seventh cycle. Menotropin treatment, however, is less expensive and carries a smaller risk than the surgical approach employed in IVF or GIFT. On the basis of these observations and our collected G I F T data which demonstrates a pregnancy rate of up to 30% for the unexplained infertility group, it may be concluded that IVF or G I F T should be employed as 'second line' modalities only following the failure of menotropin treatment. The prevalence of endometriosis among infertile women is 25-35% [44] and different degrees of severity exist within this population. When severe endometriosis causes adhesions and mechanical infertility, IVF-ET is the treatment of choice, while for infertility caused by mild to moderate endometriosis, G I F T may be the option of choice. Some studies report a clinical pregnancy rate of 30% (Fig. 4), although sufficient data, such as severity of disease, are not available. Tubal pathology is a minor indication for G I F T treatment worldwide and at least one tube should be patent for G I F T to be feasible. In case of tubal pathology, IVFET is superior to G I F T and indeed more than 50% of the indications for IVF-ET are tubal factor infertility

63

[45] while only 6-15% of G I F T cycles are for tubal factor infertility treatment. When only one tube is cannulated, Haines and O'Shea [26] have shown that G I F T success rates are similar to bilateral tubal cannulation. There are no reports on whether G I F T treatment in this group of patients carries a higher risk of ectopic pregnancies. According to most reports and on theroretical grounds, IVF-ET and not G I F T should be the common practice for tubal factor infertility. There are several other indications for G I F T treatment, such as immunological infertility, cervical factor infertility and anovulation. Further data concerning success rates for those indications are necessary in order to properly evaluate the place of each category in G I F T treatment today. Older women participating in G I F T programs adversely affect G I F T results [46]. There has been controversy over the age limits for women candidates for assisted reproduction procedures and a few centers actually limit the age for women candidates in order to avoid a decrease in success rates. Through our data collection, it was impossible to evaluate the age of patients participating in G I F T nor the contribution of age to overall GIFT success rates. Craft and Brindsen [21] reported that the outcome of G I F T procedure in the older population is poorer but a higher pregnancy rate is obtained following the transfer of more oocytes.

4.2. Appraisal of GIFT techniques The most common protocols used for ovarian stimulation in G I F T are the same as those for IVF. Ovulation stimulation protocols such as clomiphene citrate and hMG-hCG were popular, whereas combinations using GnRH-a and hMG-hCG have recently gained in popularity [47,48]. Our survey shows that a comparison of the pregnancy rates obtained with different ovarian stimulation protocols is impossible to evaluate not only because sufficient data are not available, but also because different protocols were used at different times. Following ovarian stimulation several oocytes develop and are retrieved. The question is how many oocytes should be transferred during the G I F T procedure? Results show that the pregnancy rate increases with the number of oocytes transferred (up to four; Fig. 3). Pregnancy rates of 30% were reported when four oocytes were transferred [49]. Several reports show that the transfer of more than four oocytes results in a better pregnancy rate [9,11,19,21,27], but these results are inconsistent and there is a high multiple pregnancy rate. Therefore, in most countries the common practice is not to transfer more than four oocytes. In many cases, following ovarian stimulation, more than four mature oocytes are retrieved. In such cases the facility of a gamete laboratory and experienced personal is necessary. The excess oocytes should be used for IVF follow-

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ed by cryopreservation of the embryos allowing transfer during future cycles or followed by embryo transfer during the same cycle. Supernumerary oocytes should be neither transferred nor wasted. Tubal cannulation during the GIFT procedure raises the question of tubal damage and the incidence of ectopic pregnancies. Extrauterine pregnancy rate resulting from GIFT is 5.5%, similar to the ectopic pregnancy rate following IVF-ET (5.54%) [45] but it is higher than that of the normal population. GIFT procedure is more invasive than IVF-ET. It involves two-puncture laparoscopy, fallopian tube handling, tubal cannulation, and longer surgical time than IVF. Our data show that national registries and medical publications did not report the medical consequences of this procedure. Data which reveal patients morbidity are unavailable and therefore cannot be compared with IVF-ET. Recently, however, non-surgical ultrasoundguided fallopian tube catheterization through the uterine cervix has gained popularity and reduced the invasiveness of the GIFT procedure [50]. 4.3. Pregnancy outcome

Our data indicate overall pregnancy rates of 24% per treatment cycle or 29% per retrieval, which is higher than the rate for IVF-ET: 14% per treatment cycle [45] and 19% per retrieval [51]. However, in order to evaluate the best treatment options for patients, the overall success rates are insufficient and it is necessarry to compare the results for each cause of infertility separately. Few reports related to this question (Fig. 4) and it seems that pregnancy rates for male factor infertility are the lowest. Further data collection and comparison of resuits from other assisted reproduction techniques will direct physicians toward the appropriate treatment option for an infertile couple. Very few publications reported abortion rates following GIFT. Extremely high cumulative abortion rates (up to 42%) represent early results during the first years in which the GIFT procedure was used. IVF, by comparison, had a reported abortion rate as high as 38% during 1985 but dropped to 20-22% during the following years [45]. The overall spontaneous abortion rates of the registries (15-22%; Table 1) is similar to IVF results [51]. The higher rate of spontaneous abortion among pregnancies following assisted reproduction may be related to older age, ovulation induction treatment, bad obstetric history, or higher multiple pregnancies rates. Further data will reveal whether GIFT really bears greater risk for spontaneous abortions. The incidence of multiple pregnancies following GIFT is 25% (19.5% twins, 4.6% triplets, and 0.3% quadruplets or more). These data are similar to IVF results which report 22-24% multiple pregnancy rates [451. As some results show [24], the more oocytes

transferred, the higher the pregnancy and multiple pregnancy rate. The latter is associated with increased maternal morbidity, abortions, and prematurity. Prematurity is responsible for increased perinatal morbidity and mortality. As all reports show, GIFT is not associated with an increased incidence of major malformations or chromosomal anomalies. The reported rate, 2.8%, is similar to the 2.25% reported for IVF-ET [45]. What is the place of GIFT today? This procedure is simple, less expensive and carries an overall higher pregnancy rate than IVF, but on the other hand, it is more invasive. In many couples, especially with unexplained infertility, conception will occur spontaneously or following minor treatment, therefore GIFT should be kept as a second line mode of treatment. GIFT treatment is not sufficient for several groups of patients. Micromanipulation rather than GIFT is indicated for severe male factor infertility and fertilization capacity can be proven by other procedures such as ZIFT, TET or IVF-ET. Severe tubal disease is best treated by means of IVF-ET. Although we evaluated GIFT results on a large scale, several questions still remain unanswered. Therefore, quality control committees in each country and detailed world collaboration reports may bring about an improvement in assisted reproduction techniques and results in general and indicate the actual place of GIFT today. References [1] Cohen J. The efficiency and efficacy of IVF and GIFT. Hum Reprod 1991; 6: 613-618. [2] World Collaborative Report, Bilan Mondial, 1989, 7th World Congress on In Vitro Fertilization and Assisted Procreation, Paris, France, June-July, 1991. [3] World Collaborative Report, 1991, 8th World Congress on In Vitro Fertilization and Alternate Assisted Reproduction, Kyoto, Japan, September 1993. [4] National Perinatal Statistics Unit and Fertility Society of Australia. IVF and GIFT Pregnancies: Australia and New Zealand, 1986. Sydney: National Perinatal Statistics Unit, 1987. [5] National Perinatal Statistics Unit and Fertility Society of Australia. IVF and GIFT Pregnancies: Australia and New Zealand, 1987. Sydney: National Perinatal Statistics Unit, 1988. 16] National Perinatal Statistics Unit and Fertility Society of Australia. IVF and GIFT Pregnancies: Australia and New Zealand, 1988. Sydney: National Perinatal Statistics Unit, 1991. [7] National Perinatal Statistics Unit and Fertility Society of Australia. IVF and GIFT Pregnancies: Australia and New Zealand, 1989. Sydney: National Perinatal Statistics Unit, 1991. I8] National Perinatal Statistics Unit and Fertility Society of Australia. IVF and GIFT Pregnancies: Australia and New Zealand, 1991. Sydney: National Perinatal Statistics Unit, 1993. [9] De Mouzon J, Belaish-Allart J, Cohen JB et al. Analyse des r~sultats 1987: C_~nrralitrs, indications, stimulations, rang de la tentative, age de la femme. Annu Rep FIVNAT Assoc, 1987. [101 De Mouzon J, Belaish-Allart J, Cohen JB et al. Analyse des rrsuitats 1988: G~nrralitrs, indications, stimulations, rang de la tentative, age de la femme. Annu Rep FIVNAT Assoc, 1988. [11] De Mouzon J, Belaish-Allart J, Cohen JB et al. Analyse des

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