Trends in Egg Donation. Vitaly A. Kushnir MD Center for Human Reproduction

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1 Trends in Egg Donation Vitaly A. Kushnir MD Center for Human Reproduction

2 Disclosures No relevant financial relationships to disclose CHR views the commercial trade in human oocytes with considerable ethical concerns. CHR does not derive profit from managing the process of egg donation, and offers donor matching services as an unreimbursed courtesy to the center s patients. CHR prices the anonymous exchange of eggs between donors and recipients in its program at cost, and without profit margin.

3 Women are delaying pregnancy

4 Age and Female Fertility

5 Aging and Ovarian Reserve Gleicher N, Kushnir VA, Barad DH. Endocrinology Oct;154(10):

6 Oocyte Aneuploidy and Age

7 CHR Patients Age and Ovarian Reserve

8 Kawwass JF et al. JAMA. 2013

9 Live Born Infants after Third Party Reproduction 13,523, 12% 5,352, 5% 3,244, 3% 13,408, 11% 79,797, 69% Oocyte Donation Embryo Donation Multiple Third Party ART Sperm Donation Gestational Carrier Kushnir et al. AJOG, 2017

10 Kushnir et al. AJOG, 2017

11 Kushnir et al. AJOG, 2017

12 Demand for donors race Shapiro AJ, Darmon SK, Barad DH, Albertini DF, Gleicher N, Kushnir VA. Effect of Race and Ethnicity on Utilization and Outcomes of ART in the USA. Reprod Biol Endocrinol. 2017

13 Fertility rates are rapidly declining -Especially among Hispanic women Utilization of ART is inversely related to fertility rates and age at first birth in the general population Utilization of ART is high among Asian and Caucasian women and low among Black and Hispanic women Utilization of third party ART/egg donation is increasing more rapidly than autologous ART Shapiro AJ, Darmon SK, Barad DH, Albertini DF, Gleicher N, Kushnir VA. Effect of Race and Ethnicity on Utilization and Outcomes of ART in the USA. Reprod Biol Endocrinol. 2017

14 Patient race is correlated with ART live birth rates Black women have the lowest live birth rates with ART Shapiro AJ, Darmon SK, Barad DH, Albertini DF, Gleicher N, Kushnir VA. Effect of Race and Ethnicity on Utilization and Outcomes of ART in the USA. Reprod Biol Endocrinol. 2017

ART live birth rates are lower while spontaneous abortion rates are higher among Black women even with egg donation Shapiro AJ, Darmon SK, Barad

15 ART live birth rates are lower while spontaneous abortion rates are higher among Black women even with egg donation Shapiro AJ, Darmon SK, Barad DH, Albertini DF, Gleicher N, Kushnir VA. Effect of Race and Ethnicity on Utilization and Outcomes of ART in the USA. Reprod Biol Endocrinol. 2017

16 Cross-Border Reproductive Care Access to care Cost Privacy Regulation laws that restrict payment to donors require disclosure of the identity of donors sex selection gestational surrogacy

17 Cross-Border Reproductive Care Non-U.S. resident cycles were associated with a 3-fold higher utilization of PGD (19.1% vs. 5.3%), a 4-fold higher utilization of oocyte donation (42.6% vs 10.6%), and a 8-fold higher use of gestational carriers (12.4% vs 1.6%).

18 Effect of PGS on Live Birth Rates in U.S. Oocyte Donor Cycles % 60.0% 55.0% 50.0% 45.0% 40.0% Fresh Transfer FET 1 FET2 FET3 non-pgs PGS Barad DH, Darmon SK, Kushnir VA, Albertini DF, Gleicher N. Am J Obstet Gynecol. 2017

19 Fertil Steril Jan;99(1):37-43.

20 Commodification of Human Eggs Ethnicity Education Employment Esthetics

21 Fresh and Cryopreserved Donor Oocyte cycles reported to SART, Fresh Donor Oocytes Year(s) ^ Cryopreserved Donor Oocytes ^ Number of cycles Embryos transferred % Cancelled Cycles Kushnir VA et al, J Ovarian Res Jan 5;11(1):2.

22 Live Birth Rate per recipient cycle start (%) Live birth rates with fresh vs. cryopreserved donated oocytes, ^ Fresh Donor Oocytes Cryopreserved Donor Oocytes Kushnir VA et al, J Ovarian Res Jan 5;11(1):2.

23 Adjusted for significant risk factors from the set of all possible cycle-level risk factors. -patient age, number of prior births and diagnoses of ovulatory dysfunction and tubal factor infertility. Donor cryopreserved oocyte cycles had decreased likelihood of live birth (arr 0.87, 95% CI ) Crawford et al. Fertil Steril (2017)

24 Fresh Oocyte Donation Advantages Disadvantages Gold Standard Practiced since 1983 Documented safety and efficacy Highest Live Birth Rates Complicated logistics High cost Donor pool vs. agency Waiting periods Long distance travel Kushnir VA, Gleicher N. Curr Opin Endocrinol Diabetes Obes. 2016

25 Cryopreserved Oocyte Donation Advantages Disadvantages Simplified Logistics Improved selection of donors Long distance shipping Lower Cost per Treatment? Improved safety due to quarantine Limited number of eggs Lower Live Birth Rates Variability in Freeze/Thaw technique? Cost per Live Birth? Long Term Health Kushnir VA, Gleicher N. Curr Opin Endocrinol Diabetes Obes. 2016

26 Key Points Fertility rates are declining Utilization of ART is inversely related to age at first birth and fertility rates in the general population Utilization of egg donation is particularly high among Asian and Caucasian women and low among Black and Hispanic women ART live birth rates are lower while spontaneous abortion rates are higher among Black women even with egg donation Reliance on egg donation increases with maternal age, it accounts for the majority of ART live birth to women above age 40

28 Are frozen donor eggs in donor-recipient cycles really the equal of fresh oocytes? Vitaly A. Kushnir MD Center for Human Reproduction

29 Disclosures No relevant financial relationships to disclose CHR views the commercial trade in human oocytes with considerable ethical concerns. CHR does not derive profit from managing the process of egg donation, and offers donor matching services as an unreimbursed courtesy to the center s patients. CHR prices the anonymous exchange of eggs between donors and recipients in its program at cost, and without profit margin.

30 Oocyte Cryopreservation Cryopreservation Storage Thawing

31 Fertil Steril Jan;99(1):37-43.

2014 Jan 1;16(1):57-62. Klitzman RL, Sauer MV.

32 Commodification of Human Eggs Krawiec KD. Egg-donor price fixing and Kamakahi v. ASRM. Virtual Mentor Jan 1;16(1): Klitzman RL, Sauer MV. Kamakahi vs ASRM and the future of compensation for human eggs. Am J Obstet Gynecol Aug;213(2): e1.

33 Commodification of Human Eggs Ethnicity Education Employment Esthetics

Donor Oocyte Vitrification Program- SPAIN (IVI) 2007 2013 (n= 3,467 cycles) Oocyte survival rate was 90.

34 Donor Oocyte Vitrification Program- SPAIN (IVI) (n= 3,467 cycles) Oocyte survival rate was 90.4% Implantation 39% Delivery rate/donation cycle 39.1% CDR/donation cycle was 78.8% Cobo A, Fertil Steril Dec;104(6): e1-8.

35 Fresh vs. Cryopreserved Oocyte Donation Kushnir et al. JAMA 2015

36 Fresh vs. Cryopreserved Oocyte Donation Kushnir VA, Gleicher N. Curr Opin Endocrinol Diabetes Obes. 2016

37 Fresh and Cryopreserved Donor Oocyte cycles reported to SART, Fresh Donor Oocytes Year(s) ^ Cryopreserved Donor Oocytes ^ Number of cycles Embryos transferred % Cancelled Cycles Kushnir VA et al, J Ovarian Res Jan 5;11(1):2.

38 Live Birth Rate per recipient cycle start (%) Live birth rates with fresh vs. cryopreserved donated oocytes, ^ Fresh Donor Oocytes Cryopreserved Donor Oocytes Kushnir VA et al, J Ovarian Res Jan 5;11(1):2.

-patient age, number of prior births and diagnoses of ovulatory dysfunction and

39 Adjusted for significant risk factors from the set of all possible cycle-level risk factors. -patient age, number of prior births and diagnoses of ovulatory dysfunction and tubal factor infertility. Donor cryopreserved oocyte cycles had decreased likelihood of live birth (arr 0.87, 95% CI ) Crawford et al. Fertil Steril (2017)

40 Fresh Oocyte Donation Advantages Disadvantages Gold Standard Practiced since 1983 Documented safety and efficacy Highest Live Birth Rates Complicated logistics High cost Donor pool vs. agency Waiting periods Long distance travel Kushnir VA, Gleicher N. Curr Opin Endocrinol Diabetes Obes. 2016

41 Cryopreserved Oocyte Donation Advantages Disadvantages Simplified Logistics Improved selection of donors Long distance shipping Lower Cost per Treatment? Improved safety due to quarantine Limited number of eggs Lower Live Birth Rates Variability in Freeze/Thaw technique? Cost per Live Birth? Long Term Health Kushnir VA, Gleicher N. Curr Opin Endocrinol Diabetes Obes. 2016

42 Technical Considerations Vitrification vs. Slow Freezing Open vs. Closed Systems Automated Systems Embryo Selection Techniques -Routine Blastocyst Culture -PGS

44 Oocyte Cryopreservation Vitrification (Rapid) Slow-freeze Cil AP, Bang H, Oktay K. Fertil Steril Aug;100(2):492-9.e3

45 Open vs. Closed System RCT of sibling donor oocytes to evaluate thaw survival Thaw survival rates (93.7 vs. 89.9%) Most embryology parameters were similar The clinical pregnancy rate per transfer was 36.5% De Munck N, et al. Open versus closed oocyte vitrification in an oocyte donation programme: a prospective randomized sibling oocyte study. Hum Reprod Feb;31(2):377-84

46 Closed System Prospective, observational, cohort, noninferiority trial. Papatheodorou. Fertil Steril. 2016

47 Automated Vitrification

48 Key Points Fresh oocyte donation should be viewed as the "gold standard" against which newer procedures, such as cryopreserved donor oocytes, are compared. Acceptable but somewhat lower live birth rates have been achieved with use of cryopreserved donated oocytes in comparison to fresh donor oocytes. Use of cryopreserved donated oocytes may simplify logistics and lower the cost per treatment cycle but whether they lower cost per live birth is still unknown. Long term follow-up studies on the health of children conceived from cryopreserved oocytes are still lacking. Establishment of donor oocyte banks formalizes commodification of human oocytes

How effective is egg freezing as a preventative treatment for young women in securing their ability to reproduce later in life?

How effective is egg freezing as a preventative treatment for young women in securing their ability to reproduce later in life? Vitaly A. Kushnir MD Center for Human Reproduction New York City Milestones