GnRH for Luteal Support in IVF/ICSI/FET Cycles

NCT ID: NCT02357654

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

see above

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GnRH agonist

Group Type EXPERIMENTAL

GnRH

Intervention Type DRUG

single shot of GnRH agonist

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GnRH

single shot of GnRH agonist

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* day 3 transfers
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Reproductive Associates

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter G McGovern, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Reproductive Associates

Hasbrouck Heights, New Jersey, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Peter G McGovern, MD

Role: CONTACT

201-288-6330

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21975790 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20825643 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRO20140001128

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.