drugset / Trial / NCT05286554
Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support
RandomizedParallel-groupOpen-labelTreatment
Summary
Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. Alterations in the peri-implantation environment are considered to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.
Timeline
- Start
- 2022-03-17
- Primary completion
- 2023-10-27
- Completion
- 2024-01-18
Publications
- Background de Ziegler D, Pirtea P, Andersen CY, Ayoubi JM. Role of gonadotropin-releasing hormone agonists, human chorionic gonadotropin (hCG), progesterone, and estrogen in luteal phase support after hCG triggering, and when in pregnancy hormonal support can be stopped. Fertil Steril. 2018 May;109(5):749-755. doi: 10.1016/j.fertnstert.2018.03.006.
- Background Thomsen LH, Kesmodel US, Andersen CY, Humaidan P. Daytime Variation in Serum Progesterone During the Mid-Luteal Phase in Women Undergoing In Vitro Fertilization Treatment. Front Endocrinol (Lausanne). 2018 Mar 19;9:92. doi: 10.3389/fendo.2018.00092. eCollection 2018.
- Background Shoham G, Leong M, Weissman A. A 10-year follow-up on the practice of luteal phase support using worldwide web-based surveys. Reprod Biol Endocrinol. 2021 Jan 26;19(1):15. doi: 10.1186/s12958-021-00696-2.
- Background Wang NF, Bungum L, Skouby SO. What is the optimal luteal support in assisted reproductive technology? Horm Mol Biol Clin Investig. 2021 Feb 22;43(2):225-233. doi: 10.1515/hmbci-2020-0081.
- Background Balasch J, Martinez F, Jove I, Cabre L, Coroleu B, Barri PN, Vanrell JA. Inadvertent gonadotrophin-releasing hormone agonist (GnRHa) administration in the luteal phase may improve fecundity in in-vitro fertilization patients. Hum Reprod. 1993 Jul;8(7):1148-51. doi: 10.1093/oxfordjournals.humrep.a138210.
- Background Tesarik J, Hazout A, Mendoza C. Enhancement of embryo developmental potential by a single administration of GnRH agonist at the time of implantation. Hum Reprod. 2004 May;19(5):1176-80. doi: 10.1093/humrep/deh235. Epub 2004 Apr 7.
- Background Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.
- Background Fusi FM, Arnoldi M, Bosisio C, Lombardo G, Ferrario M, Zanga L, Galimberti A, Capitanio E. Ovulation induction and luteal support with GnRH agonist in patients at high risk for hyperstimulation syndrome. Gynecol Endocrinol. 2015;31(9):693-7. doi: 10.3109/09513590.2015.1025379. Epub 2015 Aug 31.
- Background Ma X, Du W, Hu J, Yang Y, Zhang X. Effect of Gonadotrophin-Releasing Hormone Agonist Addition for Luteal Support on Pregnancy Outcome in vitro Fertilization/Intracytoplasmic Sperm Injection Cycles: A Meta-Analysis Based on Randomized Controlled Trials. Gynecol Obstet Invest. 2020;85(1):13-25. doi: 10.1159/000501204. Epub 2019 Aug 16.
- Background Aboulghar MA, Marie H, Amin YM, Aboulghar MM, Nasr A, Serour GI, Mansour RT. GnRH agonist plus vaginal progesterone for luteal phase support in ICSI cycles: a randomized study. Reprod Biomed Online. 2015 Jan;30(1):52-6. doi: 10.1016/j.rbmo.2014.09.017. Epub 2014 Oct 13.
- Background Isikoglu M, Ozgur K, Oehninger S. Extension of GnRH agonist through the luteal phase to improve the outcome of intracytoplasmic sperm injection. J Reprod Med. 2007 Jul;52(7):639-44.
- Background Martins WP, Ferriani RA, Navarro PA, Nastri CO. GnRH agonist during luteal phase in women undergoing assisted reproductive techniques: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 2016 Feb;47(2):144-51. doi: 10.1002/uog.14874. Epub 2015 Dec 30.
- Background Qu D, Li Y. Multiple-dose versus single-dose gonadotropin-releasing hormone agonist after first in vitro fertilization failure associated with luteal phase deficiency: A randomized controlled trial. J Int Med Res. 2020 Jun;48(6):300060520926026. doi: 10.1177/0300060520926026.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Triptorelin | Other / unclassified | 0.1 mg | Subcutaneous |
| Background | Progesterone | Other / unclassified | 400 mg | Intravenous |