drugset / Trial / NCT02635607
Effectiveness and Safety Study of Fixed Versus Flexible of Gonadotropin-releasing Hormone Antagonist Protocol
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of study is to compare the effectiveness of the Day-5 fixed administration of GnRH antagonist versus flexible administration of GnRH antagonist during ovarian stimulation in Chinese women with predicted high ovarian response, and the hypotheses is that the number of oocyte retrieved in fixed protocol is not inferior to GnRH antagonist flexible protocol.
Timeline
- Start
- 2016-01
- Primary completion
- 2016-12
- Completion
- 2017-03
Publications
- Background Humaidan P, Quartarolo J, Papanikolaou EG. Preventing ovarian hyperstimulation syndrome: guidance for the clinician. Fertil Steril. 2010 Jul;94(2):389-400. doi: 10.1016/j.fertnstert.2010.03.028. Epub 2010 Apr 22.
- Background Al-Inany HG, Youssef MA, Aboulghar M, Broekmans F, Sterrenburg M, Smit J, Abou-Setta AM. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2011 May 11;(5):CD001750. doi: 10.1002/14651858.CD001750.pub3.
- Background Lainas TG, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas GT, Alexopoulou E, Kolibianakis EM. Flexible GnRH antagonist protocol versus GnRH agonist long protocol in patients with polycystic ovary syndrome treated for IVF: a prospective randomised controlled trial (RCT). Hum Reprod. 2010 Mar;25(3):683-9. doi: 10.1093/humrep/dep436. Epub 2009 Dec 15.
- Background Al-Inany H, Aboulghar MA, Mansour RT, Serour GI. Optimizing GnRH antagonist administration: meta-analysis of fixed versus flexible protocol. Reprod Biomed Online. 2005 May;10(5):567-70. doi: 10.1016/s1472-6483(10)61661-6.
- Background Hamdine O, Eijkemans MJ, Lentjes EW, Torrance HL, Macklon NS, Fauser BC, Broekmans FJ. Ovarian response prediction in GnRH antagonist treatment for IVF using anti-Mullerian hormone. Hum Reprod. 2015 Jan;30(1):170-8. doi: 10.1093/humrep/deu266. Epub 2014 Oct 29.
- Background Engmann L, DiLuigi A, Schmidt D, Nulsen J, Maier D, Benadiva C. The use of gonadotropin-releasing hormone (GnRH) agonist to induce oocyte maturation after cotreatment with GnRH antagonist in high-risk patients undergoing in vitro fertilization prevents the risk of ovarian hyperstimulation syndrome: a prospective randomized controlled study. Fertil Steril. 2008 Jan;89(1):84-91. doi: 10.1016/j.fertnstert.2007.02.002. Epub 2007 Apr 26.
- Luo X, Pei L, Li F, Li C, Huang G, Ye H. Fixed versus flexible antagonist protocol in women with predicted high ovarian response except PCOS: a randomized controlled trial. BMC Pregnancy Childbirth. 2021 May 2;21(1):348. doi: 10.1186/s12884-021-03833-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ganirelix | Protein / enzyme biologic | 0.25 mg | Subcutaneous |
| Background | Follitropin beta | Protein / enzyme biologic | 150 iu | Subcutaneous |
| Background | Triptorelin | Other / unclassified | 0.2 mg | — |
| Background | rhCG | Unknown | 250 ug | — |