IN VITRO FERTILIZATION

Transcription

1 FERTILITY AND STERILITY VOL. 76, NO. 1, JULY 2001 Copyright 2001 American Society for Reproductive Medicine Published by Elsevier Science Inc. Printed on acid-free paper in U.S.A. IN VITRO FERTILIZATION Does increasing ovum donor compensation lead to differences in donor characteristics? Erica K. German, A.B., Tanmoy Mukherjee, M.D., Deserie Osborne, B.S., and Alan B. Copperman, M.D. Division of Reproductive Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, Mount Sinai School of Medicine, New York, New York Objective: To evaluate the effects of a compensation increase for anonymous ovum donors on demographic and social characteristics. Design: Retrospective analysis. Setting: The Mount Sinai Medical Center Ovum Donation Program. Patient(s): All program applicants for 2 years preceding (group I, n 2,934) and 1 year following an increase in donor compensation (group II, n 1,114; total N 4,048). Intervention(s): Compensation was increased from $2,500 to $5,000 per cycle. Main Outcome Measure(s): Demographic and social characteristics of applicants and donors. Result(s): More group II applicants (65.7%) than group I applicants (49.2%) returned an initial biographical questionnaire. Compensation level did not affect the percentage rejected at any stage in the application process or ultimately selected. There were no differences in donors in age, marital status, education, race, religion, or psychological profile. Group II donors had more previous pregnancies (group II mean 1.2, group I mean 0.6) and previous abortions (group II mean 0.8, group I mean 0.4). Conclusion(s): Increasing compensation may result in a higher percentage of potential donors completing an initial questionnaire but does not alter the demographic and social characteristics of selected donors. Adherence to a rigorous applicant screening ensures that donor characteristics remain independent from compensation. (Fertil Steril 2001;76: by American Society for Reproductive Medicine.) Key Words: Ovum donation, donor compensation, assisted reproductive technologies Received September 5, 2000; revised and accepted January 23, Presented at the 56th Annual Meeting of the American Society for Reproductive Medicine, San Diego, California, October 21 26, Reprint requests: Alan B. Copperman, M.D., Division of Reproductive Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences, The Mount Sinai School of Medicine, 1212 Fifth Avenue, New York, New York (FAX: ; alan.copper man@mssm.edu) /01/$20.00 PII S (01) In May 1998, several New York City based anonymous ovum donation programs increased their compensation of donors from $2,500 per completed cycle to $5,000 per completed cycle. There continues to be discussion and controversy as to whether this increase in compensation would lead to differences in the demographic and social characteristics of women applying and being selected to donate eggs. This study considered ovum donor applicants and donors at one large program in New York City to determine whether the change in compensation occurring 1 year ago resulted in differences in donor characteristics. Controversy has existed for many years over whether tissue donors of any type, from blood donor to gamete donor, should be compensated. Recently, the debate has intensified in the area of ovum donation, as compensation has increased to levels considered unreasonable by some. At many ovum donation centers, the demand for donor ova exceeds the available supply, and it would seem intuitive that an increase in compensation would lead to an increased supply of donors. Opponents of overcompensation, or even of any compensation, fear that an exchange of money may have negative ramifications. Proposed negative consequences include the potential exploitation of women of low socioeconomic status who are desperate to make money and the chance that potential donors may falsify information to be accepted as donors, leading to an increased risk of transmitting infectious and/or genetic diseases (1). Additionally, it has been argued that pay- 75

2 ments to egg donors may, in fact, be coercive, resulting in donors who later come to regret their decisions to serve as ovum donors (2). American guidelines have mandated that payments to gamete donors are intended to compensate donors for their time, discomfort, risk, and inconvenience and are not meant to induce women to donate oocytes (3, 4). Many authorities have argued that levels of compensation have reached far beyond amounts that would merely compensate and have led women to donate who might not have chosen to do so if the compensation were lower (5, 6). In designing this study, we set out to determine if the change in donor compensation occurring in 1998 at the Mt. Sinai Medical Center Ovum Donation Program would lead to differences in the demographic and social characteristics of program applicants and eventual donors. Applicants to the donor program were compared to see whether similar proportions of applicants were selected and rejected at various steps in the application/evaluation process before and after the compensation change, and those women who were chosen to serve as donors before and after the compensation change were compared on different social and epidemiologic variables. METHODS Donor Applicant Analysis Applicants to the donor program were compared to see if similar proportions of applicants were selected and rejected at various steps in the application/evaluation process before and after the compensation change. Group I consisted of women who initially contacted the program, in response to advertisements in New York magazines and newspapers, between June 1996 and May 1998, the low-compensation ($2,500) period, and Group II consisted of women who contacted the program between June 1998 and May 1999, the high-compensation ($5,000) period. Because the entire application process may take several months from time of initial contact to ultimately being selected and serving as a donor, for the purpose of our study, applicants were considered in the time period in which they initially contacted the program, as it was that time which determined which level of compensation they had seen advertised. There were several donors who donated once during the low-compensation time period and later returned to donate a second time after the compensation rate had increased, but they were counted only in the low-compensation time period, as it was under those compensation conditions that they were initially willing to participate. An applicant calling the program in response to an advertisement is given a short initial telephone screening consisting of several basic health-related questions. If she passes this screening, she is sent a more detailed biographical questionnaire to complete and return. Our first comparison between the two compensation groups was to measure and compare the proportion of initial callers who passed the phone screening and were sent the more detailed questionnaire. The longer, mailed questionnaire consists of questions eliciting health, social, and epidemiologic information including occupation, education, ethnicity, blood type, special interests including academic, musical, and athletic skills, personal habits related to alcohol, tobacco, and recreational drug use, general health information concerning diet and sleep, genetic history, family health history, previous surgeries or illnesses, medications taken in the previous year, questions about gynecologic history, sexual history, and about any living children the applicant may have. Our next measure was to compare the proportion of women in each compensation level who completed and returned this questionnaire after being invited to do so. After the return of this questionnaire, suitable candidates undergo a psychological evaluation, including a clinical interview by the program psychologist and the administration of several tests, including the Minnesota Multiphasic Personality Inventory II (MMPI-II), the Life Events Checklist, the Wechsler Adult Intelligence Scale: Comprehension Subtest and Similarities Subtest, and the Sentence Completion Test. This study compared the proportion of women in each compensation category who were offered such an evaluation after returning their mailed questionnaires. Candidates then meet with the program physicians for a thorough assessment, including history and physical examination. We compared, between the two groups, the proportion of women interviewed who were subsequently eliminated as participants for each of the following reasons: [1] health history or genetics, including advanced age ( 31 years of age); [2] positive history of sexually transmitted infections; [3] having obtained a tattoo within the previous 2 years (to protect against blood-borne disease transmission); [4] becoming pregnant during the application process; [5] voluntarily dropping out of the program; [6] negative psychological evaluation or MMPI-II score; or [7] because no suitable match was found among recipients. Finally, we compared the proportion of initial callers in each compensation period who eventually served as donors. Using SPSS statistical software for Windows, 2 and Fisher s exact tests were used to evaluate categorical variables between groups (version 7.5; SPSS Inc., Chicago, IL). Donor Analysis This study compared donors selected from group I and group II on several social and epidemiologic characteristics, including age; marital status (single, divorced, separated, or married); educational level (high school graduate, at least some college, or at least some graduate school); race (Caucasian or non-caucasian); religion (Christian, Jewish, other, or no religion); scores on two portions of the Wechsler Adult Intelligence Scale, the Comprehension subtest, and the Sim- 76 German et al. Increasing ovum donor compensation Vol. 76, No. 1, July 2001

3 TABLE 1 Donor applicant comparisons. 6/96-5/98 6/98-5/99 P value a No. of callers 2,934 1,114 Questionnaires sent to callers 779 (26.6%) 364 (32.7%).005 Questionnaires completed by callers 383 (49.2%) 239 (65.7%).005 Granted interviews after returning questionnaire 158 (41.3%) 89 (37.2%).32 Interviewed and cancelled due to history or genetics (including advanced age) 24 (15.2%) 11 (12.4%).54 Interviewed and cancelled due to positive history of STIs 2 (1.3%) 1 (1.1%) 1.00 b Interviewed and cancelled due to tattoo within previous 2 years 2 (1.3%) 4 (4.5%).19 b Interviewed and cancelled due to becoming pregnant 1 (0.6%) 2 (2.2%).30 b Interviewed who dropped out citing personal reasons 81 (51.3%) 53 (59.6%).21 Interviewed and cancelled due to negative psychological evaluation 9 (5.7%) 4 (4.5%).78 b Interviewed and cancelled because no match was found 2 (1.3%) 0 (0.0%).54 b Initial callers who served as donors 37 (1.3%) 14 (1.3%).99 a Determined by Pearson 2, unless otherwise noted. Determined by Fisher s exact test, 2-sided. German. Increasing ovum donor compensation. Fertil Steril ilarities subtest; score on Minnesota Multiphasic Personality Inventory II (MMPI-II); number of previous pregnancies; number of previous abortions; number of previous live births; and history of sexually transmitted infections. Finally, the two groups were compared on the average number of eggs retrieved per cycle. We applied independent-samples t-tests to compare the two groups on continuous variables and 2 and Fisher s exact tests to compare the two groups on categorical variables. RESULTS Donor Applicant Comparison Table 1 provides a summary of our comparisons between donor applicants in groups I and II. Significantly, we found that a higher proportion of the women in group II than in group I completed and returned the biographical questionnaire (65.7% vs. 49.2%, respectively; P.01). There were no other significant differences between the donor applicants in the two different compensation groups. Similarly, no significant difference was found between compensation groups in the proportion of initial callers who eventually served as donors. This study had an 80% power to detect a 50% difference in outcome measures. Donor Comparison The comparisons between donors in groups I and II are detailed in Table 2. We found only two significant differences between the groups. Group II donors had had a significantly higher number of previous pregnancies than group I donors (mean 1.21 vs. 0.57, respectively; P.05) and a significantly higher number of previous abortions than group I donors (mean 0.79 vs. 0.38, respectively; P.05). With these exceptions, there were no other significant differences between the groups. There was a trend towards significance on two subscales of the MMPI psychopathic deviate and paranoia but when we corrected the MMPI t-tests for multiple comparisons, we chose to use a stricter P value of.01. Therefore, we do not believe that there is a statistically significant difference between the two groups on these subscales. There was also no difference in the average number of eggs retrieved per cycle from donors in the two groups. DISCUSSION As ovum donation programs in the New York City area have continued to increase donor compensation to attract donors, concern has grown also about the potential effects that rising compensation may have on the donor pool. This study is the first to systematically and quantitatively address this question. Our findings suggest that increasing compensation has no effect on the social or epidemiologic characteristics of donors. In our comparison of applicants to the program, we found a significant difference between groups in the proportion of women who completed and returned the detailed take-home questionnaire after being invited to do so; the women in the high-compensation group were more likely to complete and return the questionnaire than were women in the low-compensation group. It is possible that the higher compensation was a significantly stronger motivating factor than was the lower compensation, leading a higher proportion of the women in the high-compensation group to continue in the application process by returning the biographical questionnaire. There were no significant differences between the two groups of donor applicants in terms of the proportion eliminated from participation at various stages in the application process or because of various specific reasons. The program FERTILITY & STERILITY 77

4 TABLE 2 Donor comparisons. 6/96-5/98 6/98-5/99 P value No. of donors Age a Married 5 (13.5%) 5 (35.7%).11 b Single/divorced/separated 32 (86.5%) 9 (64.3%).11 b Highest education level high school 4 (10.8%) 2 (14.3%).90 d Highest education level at least some college 31 (83.8%) 11 (78.6%).90 d Highest education level at least some post-college 2 (5.4%) 1 (7.1%).90 d Caucasian 33 (89.2%) 11 (78.6%).38 b Non-Caucasian 4 (10.8%) 3 (21.4%).38 b Do not identify with a religion 4 (10.8%) 3 (21.4%).16 b Christian 30 (81.1%) 8 (57.1%).16 b Jewish 2 (5.4%) 1 (7.1%).16 b Other religion 1 (2.7%) 2 (14.3%).16 b Positive history of STIs 4 (10.8%) 0 (0.0%).57 b Number of previous pregnancies a Number of previous abortions a Number of previous live births a,c Average number of eggs/cycle a WAIS, Comprehension test score % %.41 a WAIS, Similarities test score % %.42 a MMPI, lie (L) a MMPI, infrequency (F) a MMPI, subtle defensiveness (K) a MMPI, hypochondriasis (HS) a,c MMPI, depression (D) a MMPI, hysteria (HY) a MMPI, psychopathic deviate (PD) a MMPI, masculine-feminine (MF) a MMPI, paranoia (PA) a MMPI, psychasthenia (PT) a MMPI, schizophrenia (SC) a MMPI, mania (MA) a MMPI, social introversion (SI) a,c a Determined by independent-samples t-test. Determined by Fisher s exact test, 2-sided. Equal variances not assumed. Determined by Mantel-Haenszel 2. German. Increasing ovum donor compensation. Fertil Steril seemed to be equally as selective in terms of eliminating potential donors, regardless of compensation group. There was also no significant difference, based on compensation group, in the proportion of initial callers eventually serving as donors. Comparing the actual donors from the two groups also yielded very few significant differences. Clearly, due to a small number of donors in each compensation group, only a large difference would have been able to be detected. We are continuing to gather and analyze these data. The only detected differences related to reproductive history. Although there was no difference in the number of previous live births based on compensation group, donors in the high-compensation group had had a significantly higher number of pregnancies and abortions than had women in the low-compensation group. The notion of compensation at any level is controversial. Opponents of high compensation fear that the high payment will lead to donors who are in poorer health (and who may make misleading statements about their condition) and who are less desirable to recipients, whereas supporters of a level of compensation determined by supply and demand believe that meeting the market value will result in a donor pool that meets the needs of recipients in terms of quality and supply of ova (7, 8). Although it is, of course, difficult to precisely quantify appropriate levels of compensation to egg donors for time and inconvenience, the Ethics Committee of the American Society for Reproductive Medicine recently opined that sums of $5,000 or more require justification and that any amount of more than $10,000 would be inappropriate (4). After thoroughly comparing our program s applicant and donor pools, we found that doubling donor compensa- 78 German et al. Increasing ovum donor compensation Vol. 76, No. 1, July 2001

5 tion from $2,500 to $5,000 did not appear to result in an altered donor population, in either a negative or positive way. Although it would seem logical that increasing donor compensation might induce women to falsify information to gain entry into the program, adherence to a rigorous and comprehensive applicant-screening program ensures that donor characteristics remain independent from donor compensation. Acknowledgment: The authors thank Robert Lapinski, Ph.D., from the Department of Obstetrics, Gynecology and Reproductive Sciences, Mount Sinai School of Medicine, New York, New York, for his assistance with statistical analysis. References 1. Shenfield F, Steele SJ. Why gamete donors should not be paid. Hum Reprod 1995;10: Johnson M. Payments to gamete donors: position of the Human Fertilisation and Embryology Authority. Hum Reprod 1997;12: The Ethics Committee of the American Fertility Society. Ethical considerations of assisted reproductive technologies. Fertil Steril 1994; 62(Suppl 1):1S 125S. 4. The Ethics Committee of the American Fertility Society. Report on financial incentives for egg donors. Fertil Steril 2000;74: Ahuja KK, Simons EG. Anonymous egg donation and dignity. Hum Reprod 1996;11: Sauer MV. Indecent proposal: $5,000 is not reasonable compensation for oocyte donors. Fertil Steril 1999;71: Englert Y. Ethics of oocyte donation are challenged by the health care system. Hum Reprod 1996;11: Bergh PA. Indecent proposal: $5,000 is not reasonable compensation for oocyte donors a reply. Fertil Steril 1999;71:9 10. FERTILITY & STERILITY 79