GnRH for Luteal Support in IVF/ICSI/FET Cycles

NCT02357654 — Phase 4, Active not recruiting, 350 participants, University Reproductive Associates

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RegistryNCT02357654
StatusActive not recruiting
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment350 (Estimated)
SponsorUniversity Reproductive Associates (Other)
ConditionsInfertility
InterventionsGnRH, placebo (Drug)
Datesstart 2015-11-01, primary completion 2027-07-01 (estimated), completion 2027-11-01 (estimated), first posted 2015-02-06, last updated 2026-10-19
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Infertility All trials of GnRH All trials of placebo

-Summary

During IVF cycles an embryo is generally placed into the uterine cavity between 3 and 5 days after fertilization. For a successful pregnancy to take place, that embryo must then implant in the properly primed and staged endometrium, which subsequently must continue to develop to accommodate the growing and maturing embryo and then fetus. This process is normally regulated by hormonal interactions between the fetal, endometrial and luteal tissue. It has been found that after IVF additional support for the endometrium with progesterone improves implantation and subsequent live birth rates in IVF cycle . Recent data has shown that additional supplementation with a single administration of a GnRH agonist around the time the time of embryo transfer may further enhance these rates .

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+Detailed description

see above

+Arms and interventions

ArmTypeInterventionsDescription
GnRH agonistExperimentalDrug: GnRH
PlaceboPlacebo comparatorDrug: placebo
  • GnRH (Drug): single shot of GnRH agonist
  • placebo (Drug): placebo

+Outcome measures

Primary outcomes

  • Live birth per transfer [9 months]

Secondary outcomes

  • implantation rates [4 weeks]
  • clinical pregnancy [4 weeks]
  • rates of OHSS [4 weeks]

+Eligibility

Sex: Female, ages: 18 Years to 40 Years

Inclusion Criteria:

* women undergoing IVF/ICSI or frozen embryo transfers (FET) that less than 40 years old.

Exclusion Criteria:

* day 3 transfers

+Locations (1)

FacilityCityCountryStatus
University Reproductive AssociatesHasbrouck Heights, New JerseyUnited States

+Publications

  • van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD009154. doi: 10.1002/14651858.CD009154.pub2. PMID 21975790
  • Oliveira JB, Baruffi R, Petersen CG, Mauri AL, Cavagna M, Franco JG Jr. Administration of single-dose GnRH agonist in the luteal phase in ICSI cycles: a meta-analysis. Reprod Biol Endocrinol. 2010 Sep 8;8:107. doi: 10.1186/1477-7827-8-107. PMID 20825643

+Investigators