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Recruiting NCT02357654

GnRH for Luteal Support in IVF/ICSI/FET Cycles

Phase IV Interventional Infertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GnRH, placebo.
Who it may be relevant to
Registry conditions: Infertility. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 .

Detailed description

see above

Interventions

  • Drug GnRH
    single shot of GnRH agonist
  • Drug placebo
    placebo

Primary outcome measures

  • Live birth per transfer [Time frame: 9 months]
Secondary outcome measures (3)
  • implantation rates [Time frame: 4 weeks]
  • clinical pregnancy [Time frame: 4 weeks]
  • rates of OHSS [Time frame: 4 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • day 3 transfers

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University Reproductive Associates — Hasbrouck Heights

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

Identifiers

NCT: NCT02357654 · PRO20140001128

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗