GnRH for Luteal Support in IVF/ICSI/FET Cycles

July 29, 2025 updated by: University Reproductive Associates
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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

see above

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Hasbrouck Heights, New Jersey, United States, 07604
        • Recruiting
        • University Reproductive Associates
        • Principal Investigator:
          • Peter G. McGovern, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • day 3 transfers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
placebo
Experimental: GnRH agonist
Drug: GnRH
single shot of GnRH agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth per transfer
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
implantation rates
Time Frame: 4 weeks
4 weeks
clinical pregnancy
Time Frame: 4 weeks
4 weeks
rates of OHSS
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Reproductive Associates

Investigators

  • Principal Investigator: Peter G McGovern, MD, Rutgers University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimated)

February 6, 2015

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO20140001128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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