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Cumulative pregnancy rates after oocyte donation
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Cumulative pregnancy rates after oocyte donation
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INFORMATION TO USERS This manuscript has been reproduced from the microfilm master. UMI films the text directly from the original or copy submitted. Thus, some thesis and dissertation copies are in typewriter face, while others may be from any type of computer printer. The quality of this reproduction is dependent upon the quality of the copy submitted. Broken or indistinct print, colored or poor quality illustrations and photographs, print bleedthrough, substandard margins, and improper alignment can adversely affect reproduction. In the unlikely event that the author did not send UMI a complete manuscript and there are missing pages, these will be noted. Also, if unauthorized copyright material had to be removed, a note will indicate the deletion. Oversize materials (e.g., maps, drawings, charts) are reproduced by sectioning the original, beginning at the upper left-hand com er and continuing from left to right in equal sections with small overlaps. Each original is also photographed in one exposure and is included in reduced form at the back of the book. Photographs included in the original manuscript have been reproduced xerographically in this copy. Higher quality 6” x 9” black and white photographic prints are available for any photographs or illustrations appearing in this copy for an additional charge. Contact UMI directly to order. UMI A Bell & Howell Information Company 300 North Zeeb Road, Ann Arbor MI 48106-1346 USA 313/761-4700 800/521-0600 Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. NOTE TO USERS This reproduction is the best copy available UMI Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. CUMULATIVE PREGNANCY RATES AFTER OOCYTE DONATION by Richard John Paulson Presented to the Faculty of The Graduate School of the University of Southern California In Partial Fulfillment of the Requirements for the Degree of Master of Science in Epidemiology December, 1998 Copyright 1998 Richard John Paulson Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. UMI Number: 13 947 83 UMI Microform 1394783 Copyright 1999, by UMI Company. All rights reserved. This microform edition is protected against unauthorized copying under Title 17, United States Code. UMI 300 North Zeeb Road Ann Arbor, MI 48103 Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. U N IV E R S IT Y O F S O U T H E R N C A L IF O R N IA T H E G R A D U A T E S C H O O L U N I V E R S I T Y P A R K L O S A N G E L E S . C A L I F O R N I A 8 0 0 0 7 This thesis, written by Richard John Paulson, M.D, under the direction of h lS . Thesis Committee, and approved by all its members, has been pre sented to and accepted by the Dean of The Graduate School, in partial fulfillment of the requirements for the degree of Master of Science in Applied Biometry/ Epidemiology D ate December 2, 1998 Stanley P . - , Azen,.Ph-D Susan Groshen, Ph-D. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. ABSTRACT CUMULATIVE PREGNANCY RATES AFTER OOCYTE DONATION Study Objective: To determine the per cycle and cumulative likelihood of pregnancy after a given number of attempts of oocyte donation. Material and Methods: Retrospective review of 418 consecutive cycles, in 276 recipients o f oocyte donation. Clinical pregnancy and delivery rates were analyzed by life-table analysis. Results: The clinical pregnancy rate per cycle was 36.2% (95% Cl 31-41%) and the cumulative pregnancy rate after four cycles was 87.9%. The delivery rate per cycle was 29.3% (95% Cl 25-33%) and the cumulative delivery rate after four cycles was 86.1%. There were no statistically significant differences in rates attributable to recipient age or diagnosis. No decline in per cycle success was noted during consecutive cycles. Conclusions: We conclude that neither recipient age nor diagnosis plays a substantial role in the success of oocyte donation, with constant success rates maintained for at least 4 consecutive cycles. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. i i TABLE OF CONTENTS List of Tables iii List of Figures iv 1. Introduction 1-2 2. Materials and Methods 3-5 3. Results 6-8 4. Discussion 9-12 5. References 13-15 Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. LIST OF TABLES Table 1: Age distribution of recipients. Table 2: Diagnostic categories of recipients of oocyte donation. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. iv LIST OF FIGURES Figure IA: Cumulative clinical pregnancy rates after oocyte donation. (A) Observed rate, (■) Mean cumulative clinical pregnancy rate (P) calculated from all mean per cycle pregnancy rate (P) by the formula: P = l-(l-f)“ where n = number of cycles. Figure IB: Cumulative clinical pregnancy rate as a function of recipient age. Figure 1C: Cumulative clinical pregnancy rate as a function of recipient diagnosis. Figure 2A: Cumulative delivery rates after oocyte donation. (A) Observed rate, (■) Mean cumulative clinical pregnancy rate (P) calculated from all mean per cycle pregnancy rate (P) by the formula: P = l-(l-f)“ where n = number of cycles. Figure 2B: Cumulative delivery rate as a function of recipient age. Figure 2C: Cumulative delivery rate as a function of recipient diagnosis. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. 1 INTRODUCTION Oocyte donation is now a well-established modality in the treatment of infertility among women.1,2 Initially intended for young women with premature ovarian failure or a heritable genetic defect, the technique has more recently been applied to women in the early peri-menopausal years3 '6 as well as after the age of the natural menopause.7,8 Because of the high success o f the procedure, it has also been applied to women with recurrent failure with standard in vitro fertilization (TVF) techniques.9,1 0 Oocyte donation represents a unique physiologic configuration, which makes possible the simultaneous optimization of embryo quality and endometrial receptivity.11,1 2 This is due to the fact that the oocytes are derived from young fertile women and the resulting embryos are transferred to the uteri of recipients, which have been previously prepared with a controlled regimen of exogenous estrogen and progesterone. It is this unique physiologic situation which has consistently produced the highest pregnancy rates of all the assisted reproductive techniques.1 3 ' 1 5 Previous retrospective studies have addressed the issue of cumulative success rates after IVF. Guzick et al.1 6 demonstrated no decline in per cycle pregnancy rates for up to six cycles. Kovacs et al.1 7 performed a similar analysis Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. and found no decline in per cycle pregnancy rates in up to eight cycles. However, no such calculation has been performed for repetitive cycles of oocyte donation. The purpose of the present study was to determine the cumulative likelihood o f pregnancy success after repetitive cycles of oocyte donation and to specifically examine the influence of recipient age and diagnosis upon the cumulative likelihood of pregnancy. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. MATERIALS AND METHODS We retrospectively analyzed the results of 418 consecutive embryo transfer cycles among 276 recipients o f oocyte donation in our institution. The protocol for oocyte donation was reviewed and approved by the Institutional Review Board of the California Medical Center Los Angeles. The recipients were divided into four age groups as detailed in Table 1. For the purpose of the analysis, all recipients were assigned to a primary diagnostic group according to the primary reason for their entry into the oocyte donation program. The diagnostic categories and the number of recipients within each category are detailed in Table 2. Table 1. Age Distribution of Recipients Aee Group n Cvcles Under 30 10 15 30-39 78 112 40-49 156 248 50-59 32 43 Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. 4 Table 2. Diagnostic categories o f recipients of oocyte donation A. Premature ovarian failure (n = 61, cycles = 90) Age under 40, with elevated serum follicle stimulating hormone (FSH) levels and amenorrhea. B. Castrate (n = 9, cycles = 16) Ail ages, with a history of bilateral oophorectomy. C. Genetic (n = 11, cycles = 12) All ages, with normal ovarian function, who elected to undergo oocyte donation in order to avoid passing their genes. D. Menopause (n = 50, cycles = 71) Age over 40 with elevated serum FSH levels and amenorrhea. E. Chemotherapy ( n = 9, cycles = 21) All ages in whom the primary reason for compromised ovarian function was a prior history of chemotherapy for malignancy. F. IVF failure (n = 70, cycles = 114) All ages with normal serum FSH levels, who had undergone at least one prior IVF attempt with a poor response to exogenous gonadotropins, or had recurrent failure with IVF in the phase of a normal response to gonadotropin stimulation. G. Transitional menopause (n = 66, cycles = 94) All ages with persistently elevated day 3 serum FSH levels in the phase of normal menstrual cyclicity. The technique of oocyte donation in our institution has previously been described in detail elsewhere.4,1 8 Briefly, donors were young fertile women, who were previously designated in either an anonymous or non-anonymous fashion. They underwent controlled ovarian hyperstimulation with a combination of Ieuprolide acetate and human menopausal gonadotropins. The recipients Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. 5 received a regimen of exogenous oral estradiol in graduated doses and intramuscular progesterone as previously described.1 8 Recipients with ovarian function were pre-treated with Ieuprolide acetate prior to initiating estrogen therapy. For the purpose of life-table analysis, only cycles prior to and including the first cycle producing either a clinical pregnancy or delivery for each recipient were included. The remaining cycles of the recipient were censored. Frozen- thawed embryo transfers were not included in the analysis. This was done because recipients were not required to transfer all frozen embryos prior to initiating another fresh cycle. Thus, recipients who conceived after a frozen embryo transfer resulting from a cycle which did not produce a pregnancy after fresh embryo transfer were counted as failures. All analyses were performed with the SAS statistical package (SAS Institute, Cary, NC) on an IBM-compatible 486-33 personal computer. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. 6 RESULTS In the clinical pregnancy analysis, o f the 418 cycles, 40 occurred in women who had previously achieved a clinical pregnancy. Thus, 378 cycles were considered evaluable. One hundred and thirty-seven total clinical pregnancies were observed (36.2%, 95% Cl 31-41%). The cumulative clinical pregnancy rate is depicted in Figure 1A. The cumulative clinical pregnancy rate as a function of age and diagnosis is depicted in Figures IB and 1C, respectively. No statistically significant differences were noted in the cumulative clinical pregnancy rates in any of the age groups or diagnostic categories. The cumulative clinical pregnancy rate after four cycles was 87.9%. In the analysis of deliveries, 18 cycles of the 418 were censored because they occurred in individuals who had previously had a delivery following a fresh embryo transfer. These 400 transfer cycles resulted in 117 deliveries (29.3%, 95% Cl 25-33%). The cumulative delivery rates are depicted in Figure 2A. The cumulative delivery rates as a function of recipient age and diagnosis are depicted in Figures 2B and 2C, respectively. No statistically significant differences were noted among any of the age groups or diagnostic categories. The cumulative delivery rate after four cycles was 86.1%. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. P ercen t 8 0 60 40 2 0 0 1 2 3 4 5 N u m b e r of cy cles 100 8 0 60 40 20 0 1 2 3 4 5 Mean PR ' Under 30 30-39 40-49 50-59 N u m b e r of cy cles P ercen t 100 80 60 40 20 0 1 2 3 4 5 "•“Msan PR POF Castrate Qenatfc M enopause Chemotherapy "*"IVF Failure ■ *" Trans, manop. N u m b e r o t cycles Figure 1. (A) Cumulative clinical pregnancy rates after opcyte donation. (A) Observed rate, (B) mean cumulative clinical pregnancy rate (P) calculated from all mean per cycle pregnancy rate (P) by the formula: P = 1 - (1 — f)n where n = number of cycles. (B) Cumulative clinical pregnancy rate as a function of recipient age. (C) Cumulative clinical pregnancy rate as a function of recipient diagnosis. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. Pmremnt 1 0 0 80 60 40 2 0 5 2 3 4 0 1 N u m b e r of eye loo P o r c o n l 100 80 60 40 20 0 4 5 1 2 3 'M ean OR ' Under 30 30-39 40-49 50-59 N u m b e r o f c y c U t P o rc o n t 100 80 60 40 20 0 2 3 1 5 4 ■ Maan PR -POP ' C astrate ■ G enetic ~ M enopause 'C hem otherapy -IVF Failure ’Trans, menop. N u m b e r of eyeloa Figure 2. (A) Cumulative delivery rates (DR) after oocyte donation. (A) Observed rate, (■) mean cumulative clinical pregnancy rate (P) calculated from all mean per cycle pregnancy rate (P) by the formula: P = I - (1 - f)n where n = number of cycles. (B) Cumulative delivery rate as a function of recipient age. (C) Cumulative delivery rate as a function of recipient diagnosis. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. 9 DISCUSSION Oocyte donation is now a well-established modality in the treatment of infertility. Since the practice o f oocyte donation utilizes oocytes which are derived from young fertile women, embryo quality is maximized in these cycles. Since the donor population is relatively homogeneous, the embryo quality component of embryo implantation is relatively constant. Accordingly, pregnancy and delivery rates are primarily dependent on the endometrial receptivity of the recipients. The annual reports from the National Registry have consistently demonstrated pregnancy and delivery rates for oocyte donation which are higher than for any of the other assisted reproductive techniques.1 3 ' 1 5 However, previously, no report or publication has addressed the issue of cumulative success rates in repetitive cycles of oocyte donation. Therefore, it has previously not been possible to determine if the average endometrial receptivity declines during successive cycles. This would be expected to occur if recipients with the highest endometrial receptivity were to conceive first. In this model, the remaining groups would be expected to have progressively decreasing success rates. However, the data presented here do not indicate decreasing success during successive cycles, suggesting that cycle failure is primarily due to chance. We found no decrease in per cycle or cumulative pregnancy and delivery rates with increasing age o f the recipient. This observation has previously been Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. 10 made by our group4 ’ 9 as well as others,1 9 though the cumulative data are presented here for the first time. In human reproduction, there is a clear age- related decline in fertility, which is manifested as a decline in monthly fecundability. There is little doubt that oocyte quality declines with age,2 0 ’2 1 but the issue of whether endometrial receptivity also declines is still somewhat controversial.2 2 The present study does not support the concept of a decline in endometrial receptivity with age and suggests that if such an effect exists, it is very small. We also found no statistically significant association between cumulative pregnancy rates and recipient diagnosis. This suggests that regardless of the cause of ovarian failure, or whether or not the ovarian failure is artificially induced with gonadotropin-releasing hormone agonists, as long as the uterine response is verified by a biopsy in a prior cycle, receptivity to embryo implantation is maintained. The advantage o f the life-table analysis is demonstrated in Figures 1C and 2C. The curves representing various diagnoses may be noted to initially vary from the mean, only to return to it in subsequent cycles. Notably, we have previously reported a statistically significant decrease in the delivery rate among patients who had previously received chemotherapy.9 This difference was not observed in the current series although this category did appear initially to have a lower delivery rate than the other categories Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. 11 (Figure 2C). O f note is also the performance of the IVF M ure category. It might be intuitive to anticipate that the endometrial receptivity would be lessened in this group since individuals with a good prognosis would presumably have been eliminated during their prior IVF attempts. However, this group was noted to perform as well as all of the other categories suggesting that prior IVF failure in this group was due either to poor oocyte production or to an artificial decrease in endometrial receptivity caused by controlled ovarian hyperstimulation1 1 or combination of the two factors.1 2 Thus, it is encouraging that individuals with prior IVF failure can be counseled that their likelihood of success with oocyte donation is no less than that of any other group of recipients. Finally, it is worthwhile to consider the concept of an intrinsic defect in endometrial receptivity. This entity is tacitly postulated in the treatment of unexplained recurrent abortion2 3 as well as recurrent TVF failure.2 4 Our data do not specifically address recurrent pregnancy loss but do suggest that regardless of etiology, reproductive failure may successfully be treated with exogenous steroid replacement and oocyte donation. It is therefore tempting to speculate that recurrent pregnancy loss may also be treated with this approach. It should be noted that ffozen-thawed embryo transfers were excluded from this analysis. The decision to exclude these cycles was made for the purpose of uniformity and accuracy of the calculations. Since at the present time, Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. 12 approximately 60% of donor recipient cycles in our program result in embryo freezing (data not shown) and success rates after frozen embryo transfer are approximately 60% of those of fresh cycles (data not shown), it is intuitive that if frozen-thawed embryo transfers are considered, then the total per aspiration pregnancy rates will rise accordingly. Consequently, the cumulative success rate after repetitive aspiration cycles would also be expected to increase. In summary, these data confirm prior observations that there does not appear to be any age-related decline in endometrial receptivity. Additionally, recipient diagnosis also does not play a significant role in per cycle or cumulative success rates. The lack of decline in success during consecutive cycles does not support the concept of an intrinsic endometrial defect in any of the groups considered here. The observed cumulative delivery rate of 86.1% after four cycles o f oocyte donation thus seems applicable to women of all ages and diagnostic categories. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. 13 REFERENCES 1. Sauer MV, Paulson RJ. Human oocyte and preembryo donation: An evolving method for the treatment of infertility. Am J Obstet Gynecol 1990; 163:1.421-4. 2. Rosenwaks Z. Donor eggs: Their application in modem reproductive technologies. Fertil Steril 1987;47:895-909. 3. Sauer MV, Paulson RJ, Lobo RA. A preliminary report on oocyte donation extending reproductive potential to women over 40. N Engl J Med 1990;323:1157-60. 4. Sauer MV, Paulson RJ, Lobo RA. Reversing the natural decline in human fertility: An extended clinical trial of oocyte donation to women of advanced reproductive age. JAMA 1992;268:1275-9. 5. Pantos K, Meimeti-Damianaki T, Vaxevanoglou T, Kapetanakis E. Oocyte donation in menopausal women aged over 40 years. Hum Reprod 1993;8:488-91. 6. Serhal PF, Craft IA. Oocyte donation in 61 patients. Lancet 1989;1:1185-97. 7. Sauer MV, Paulson RJ, Lobo RA. Pregnancy after age 50: Application of oocyte donation to women after natural menopause. Lancet 1993;341:321-3. 8. Antinori S, Versaci C, Gholami GH, Panci C, Caffa B. Oocyte donation in menopausal women. Hum Reprod 1993 ;8-1487-90. 9. Sauer MV, Paulson RJ, Ary BA, Lobo RA. Three-hundred cycles of oocyte donation at the University of Southern California: Assessing the effect of age and infertility diagnosis on pregnancy and implantation rates. J Asst Reprod Genet 1994;11:92-6. 10. Pados G, Camus M, Van Waesberghe L, Liebaers I, Van Steirteghem A, Devroey P. Oocyte and embryo donation: Evaluation of 412 consecutive trials. Hum Reprod 1992;7:1111-7. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. 14 11. Paulson RJ, Sauer MV, Lobo RA. Embryo implantation after human in vitro fertilization: Importance of endometrial receptivity. Fertil Steril 1990;53:870-4. 12. Paulson RJ, Sauer MV, Lobo RA. Factors affecting embryo implantation after human in vitro fertilization: A hypothesis. Am J Obstet Gynecol 1990;163:2020-3. 13. Medical Research International and the Society for Assisted Reproductive Technology: In vitro fertilization-embryo transfer in the United States: 1988 results from the IVF-ET Registry. Fertil Steril 1990;53:13-20. 14. Medical Research International and the Society for Assisted Reproductive Technology: In vitro fertilization-embryo transfer in the United States: 1988 results from the IVF-ET Registry. Fertil Steril 1991;55:14-23. 15. Medical Research International and the Society for Assisted Reproductive Technology: In vitro fertilization-embryo transfer in the United States: 1988 results from the IVF-ET Registry. Fertil Steril 1992;57:15-24. 16. Guzick DS, Wilkes C, Jones HW Jr. Cumulative pregnancy rates for in vitro fertilization. Fertil Steril 1986;46:663-7. 17. Kovacs GT, Rogers P, Leeton JF, Trounson AO. Wood C, Baker HW. In-vitro fertilization and embryo transfer: Prospects of pregnancy by life- table analysis. Med J Aust 1986;144:682-3. 18. Sauer MV, Macaso TM, Hernandez MF, Lobo RA, Paulson RJ. Establishment of a nonanonymous donor oocyte program. Preliminary experience at the University of Southern California. Fertil Steril 1989;52:433-6. 19. Navot D, Bergh PA, Williams MA, Garrisi GJ, Guzman I, Sandler B, et al. Poor oocyte quality rather than implantation failure as a cause o f age- related decline in female fertility. Lancet 1991;337:1375-7. 20. Rotsztejn DA, Asch RH. Effect of aging on assisted reproductive technologies (ART): Experience from egg donation. Sem Reprod Endocrinol 1991;9:272-9. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. 15 21. Scfaattman GL, Davis OK, Rosenwaks Z. Patient selection and screening for assisted reproductive technology. Infert Reprod Med Clin No Am 1993;4:619-41. 22. Meldrum DR Female reproductive aging: Ovarian and uterine factors. Fertil Steril 1993;59:1-5. 23. Kwak JYH, Gilman-Sachs A, Beaman KD, Beer AE. Reproductive outcome in women with recurrent spontaneous abortions o f alloimmune and autoimmune causes: Preconception versus postconception treatment. Am J Obstet Gynecol 1992;166:1787-98. 24. Coulam CB, Krysa LW, Bustillo M. Intravenous immunoglobulin for in- vitro fertilization failure. Hum Reprod 1994;9:2265-9. Reproduced with permission of the copyright owner. Further reproduction prohibited without permission. ,0 . | T IMAGE EVALUATION TEST TARGET (Q A -3 ) ✓ V - ✓ / <L* <• < ? , 4 i ? / , 150 A P P L I E D A IIW IGE . In c 1653 East Main Street - = -■ Rochester, NY 14609 USA Phone: 716/482-0300 - = Fax: 716/288-5989 O 1993. Applied Image. Inc.. All Righls Reserved Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.
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Paulson, Richard John
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Core Title
Cumulative pregnancy rates after oocyte donation
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Master of Science
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Epidemiology
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health sciences, obstetrics and gynecology,OAI-PMH Harvest,statistics
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Azen, Stanley (
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