drugset / Trial / NCT01367912
Timing of Estrogen Support During the Luteal Phase of in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycle
RandomizedParallel-groupSingle-blindTreatment
Summary
To test the hypothesis that adding estradiol (E2) to progesterone supplementation later in the luteal phase of in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles, rather than earlier in the luteal phase, improves clinical pregnancy rates (PRs).
Timeline
- Start
- 2008-02
- Primary completion
- 2008-11
- Completion
- 2008-11
Publications
- Background Ubaldi F, Bourgain C, Tournaye H, Smitz J, Van Steirteghem A, Devroey P. Endometrial evaluation by aspiration biopsy on the day of oocyte retrieval in the embryo transfer cycles in patients with serum progesterone rise during the follicular phase. Fertil Steril. 1997 Mar;67(3):521-6. doi: 10.1016/s0015-0282(97)80080-5.
- Background Kolibianakis EM, Devroey P. The luteal phase after ovarian stimulation. Reprod Biomed Online. 2002;5 Suppl 1:26-35. doi: 10.1016/s1472-6483(11)60214-9.
- Background Fauser BC, Devroey P. Reproductive biology and IVF: ovarian stimulation and luteal phase consequences. Trends Endocrinol Metab. 2003 Jul;14(5):236-42. doi: 10.1016/s1043-2760(03)00075-4.
- Background Devreker F, Govaerts I, Bertrand E, Van den Bergh M, Gervy C, Englert Y. The long-acting gonadotropin-releasing hormone analogues impaired the implantation rate. Fertil Steril. 1996 Jan;65(1):122-6.
- Background Daya S, Gunby J. Luteal phase support in assisted reproduction cycles. Cochrane Database Syst Rev. 2004;(3):CD004830. doi: 10.1002/14651858.CD004830.
- Background Pritts EA, Atwood AK. Luteal phase support in infertility treatment: a meta-analysis of the randomized trials. Hum Reprod. 2002 Sep;17(9):2287-99. doi: 10.1093/humrep/17.9.2287.
- Background Jee BC, Suh CS, Kim SH, Kim YB, Moon SY. Effects of estradiol supplementation during the luteal phase of in vitro fertilization cycles: a meta-analysis. Fertil Steril. 2010 Feb;93(2):428-36. doi: 10.1016/j.fertnstert.2009.02.033. Epub 2009 Apr 1.
- Background Gelbaya TA, Kyrgiou M, Tsoumpou I, Nardo LG. The use of estradiol for luteal phase support in in vitro fertilization/intracytoplasmic sperm injection cycles: a systematic review and meta-analysis. Fertil Steril. 2008 Dec;90(6):2116-25. doi: 10.1016/j.fertnstert.2007.10.053. Epub 2008 Jan 7.
- Background Kolibianakis EM, Venetis CA, Papanikolaou EG, Diedrich K, Tarlatzis BC, Griesinger G. Estrogen addition to progesterone for luteal phase support in cycles stimulated with GnRH analogues and gonadotrophins for IVF: a systematic review and meta-analysis. Hum Reprod. 2008 Jun;23(6):1346-54. doi: 10.1093/humrep/den115. Epub 2008 Apr 11.
- Background Buvat J, Marcolin G, Guittard C, Dehaene JL, Herbaut JC, Louvet AL. [Luteal support after administration of an LHRH analog for in vitro fertilization. Superiority of vaginal progesterone in comparison with oral progesterone]. Presse Med. 1990 Mar 24;19(11):527. No abstract available. French.
- Background Farhi J, Weissman A, Steinfeld Z, Shorer M, Nahum H, Levran D. Estradiol supplementation during the luteal phase may improve the pregnancy rate in patients undergoing in vitro fertilization-embryo transfer cycles. Fertil Steril. 2000 Apr;73(4):761-6. doi: 10.1016/s0015-0282(99)00632-9.
- Background Bergh PA, Navot D. The impact of embryonic development and endometrial maturity on the timing of implantation. Fertil Steril. 1992 Sep;58(3):537-42. doi: 10.1016/s0015-0282(16)55259-5.
- Background Muasher S, Acosta AA, Garcia JE, Jones GS, Jones HW Jr. Luteal phase serum estradiol and progesterone in in vitro fertilization. Fertil Steril. 1984 Jun;41(6):838-43. doi: 10.1016/s0015-0282(16)47895-7.
- Background Yang JH, Chen HF, Lien YR, Chen SU, Ho HN, Yang YS. Elevated E2: oocyte ratio in women undergoing IVF and tubal ET. Correlation with a decrease in the implantation rate. J Reprod Med. 2001 May;46(5):434-8.
- Background Valbuena D, Martin J, de Pablo JL, Remohi J, Pellicer A, Simon C. Increasing levels of estradiol are deleterious to embryonic implantation because they directly affect the embryo. Fertil Steril. 2001 Nov;76(5):962-8. doi: 10.1016/s0015-0282(01)02018-0.
- Background Smitz J, Bourgain C, Van Waesberghe L, Camus M, Devroey P, Van Steirteghem AC. A prospective randomized study on oestradiol valerate supplementation in addition to intravaginal micronized progesterone in buserelin and HMG induced superovulation. Hum Reprod. 1993 Jan;8(1):40-5. doi: 10.1093/oxfordjournals.humrep.a137871.
- Background Lukaszuk K, Liss J, Lukaszuk M, Maj B. Optimization of estradiol supplementation during the luteal phase improves the pregnancy rate in women undergoing in vitro fertilization-embryo transfer cycles. Fertil Steril. 2005 May;83(5):1372-6. doi: 10.1016/j.fertnstert.2004.11.055.
- Background Lewin A, Benshushan A, Mezker E, Yanai N, Schenker JG, Goshen R. The role of estrogen support during the luteal phase of in vitro fertilization-embryo transplant cycles: a comparative study between progesterone alone and estrogen and progesterone support. Fertil Steril. 1994 Jul;62(1):121-5. doi: 10.1016/s0015-0282(16)56826-5.
- Background Tay PY, Lenton EA. Inhibition of progesterone secretion by oestradiol administered in the luteal phase of assisted conception cycles. Med J Malaysia. 2003 Jun;58(2):187-95.
- Background Smitz J, Devroey P, Camus M, Deschacht J, Khan I, Staessen C, Van Waesberghe L, Wisanto A, Van Steirteghem AC. The luteal phase and early pregnancy after combined GnRH-agonist/HMG treatment for superovulation in IVF or GIFT. Hum Reprod. 1988 Jul;3(5):585-90. doi: 10.1093/oxfordjournals.humrep.a136750.
- Background Younis JS, Ezra Y, Sherman Y, Simon A, Schenker JG, Laufer N. The effect of estradiol depletion during the luteal phase on endometrial development. Fertil Steril. 1994 Jul;62(1):103-7. doi: 10.1016/s0015-0282(16)56823-x.
- Background Vlahos NF, Lipari CW, Bankowski B, Lai TH, King JA, Shih IeM, Fragakis K, Zhao Y. Effect of luteal-phase support on endometrial L-selectin ligand expression after recombinant follicle-stimulating hormone and ganirelix acetate for in vitro fertilization. J Clin Endocrinol Metab. 2006 Oct;91(10):4043-9. doi: 10.1210/jc.2006-0520. Epub 2006 Jul 25.
- Background Engmann L, DiLuigi A, Schmidt D, Benadiva C, Maier D, Nulsen J. The effect of luteal phase vaginal estradiol supplementation on the success of in vitro fertilization treatment: a prospective randomized study. Fertil Steril. 2008 Mar;89(3):554-61. doi: 10.1016/j.fertnstert.2007.04.006. Epub 2007 Aug 2.
- Background Gorkemli H, Ak D, Akyurek C, Aktan M, Duman S. Comparison of pregnancy outcomes of progesterone or progesterone + estradiol for luteal phase support in ICSI-ET cycles. Gynecol Obstet Invest. 2004;58(3):140-4. doi: 10.1159/000079115. Epub 2004 Jun 15.
- Background Serna J, Cholquevilque JL, Cela V, Martinez-Salazar J, Requena A, Garcia-Velasco JA. Estradiol supplementation during the luteal phase of IVF-ICSI patients: a randomized, controlled trial. Fertil Steril. 2008 Dec;90(6):2190-5. doi: 10.1016/j.fertnstert.2007.10.021. Epub 2008 Jan 14.
- Results Pouly JL, Piekrishvili R, Beaume-BrugonF, Schubert B, Janny L. Luteal phase supplementation with oestrogens doesn't improve the IVF pregnancy rate: a randomized study. Hum Reprod 2005; 20:O- 195.
- Results Tonguc E, Var T, Ozyer S, Citil A, Dogan M. Estradiol supplementation during the luteal phase of in vitro fertilization cycles: a prospective randomised study. Eur J Obstet Gynecol Reprod Biol. 2011 Feb;154(2):172-6. doi: 10.1016/j.ejogrb.2010.10.003. Epub 2010 Nov 9.
- Results Causio F, Leonetti T. Luteal phase support with estrogen and progesterone in in vitro fertilization cycles using GnRHa and FSH. Gior Ital Ostet Ginecol 1997; 19: 277-82.
- Results Rashidi BH, Asheghan H, Jafarabadi M, Tehrani NE. The role of estrogen supplementation during the luteal phase in in vitro fertilization-embryo transfer cycles: a comparative study between progesterone and estrogen plus progesterone support. Proceedings of the 18th World Congress on Fertility and sterility; 2004 May 23-28; Montreal, Canada. Internatioanal Congress Series; 2004.p.120-123.
- Results Elnashar AM, Aboul-Enein GI. Endometrial receptivity. Middle East Fertil Soc J 2004; 9 (1): 10-24).
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Estradiol | Other / unclassified | 2 mg | Oral |