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GnRH Agonist for Infertility

Phase 4
Recruiting
Led By Peter G McGovern, MD
Research Sponsored by University Reproductive Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial found that using a GnRH agonist in addition to progesterone during IVF cycles improves implantation and live birth rates.

Who is the study for?
This trial is for women under 40 years old undergoing IVF, ICSI, or frozen embryo transfers to help with infertility. It's not for those having an embryo transfer on day 3 of the process.
What is being tested?
The study tests if a single dose of GnRH agonist given around the time of embryo transfer improves implantation and live birth rates in IVF cycles compared to a placebo.
What are the potential side effects?
GnRH agonists can cause headaches, mood swings, hot flashes, and injection site reactions. These side effects are generally mild.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2009 Phase 2 trial • 36 Patients • NCT00586898
22%
Hyperglycemia
19%
Hot Flashes
17%
Dyspnea
14%
Hyperkalemia
8%
SGPT (ALT)
6%
Hypoglycemia
3%
Pneumonitis
3%
Cardiovascular, other
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Participants

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GnRH agonistExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GnRH
2017
Completed Phase 2
~640

Find a Location

Who is running the clinical trial?

University Reproductive AssociatesLead Sponsor
5 Previous Clinical Trials
109 Total Patients Enrolled
3 Trials studying Infertility
99 Patients Enrolled for Infertility
Peter G McGovern, MDPrincipal InvestigatorRutgers University

Media Library

GnRH Clinical Trial Eligibility Overview. Trial Name: NCT02357654 — Phase 4
Infertility Research Study Groups: GnRH agonist, Placebo
Infertility Clinical Trial 2023: GnRH Highlights & Side Effects. Trial Name: NCT02357654 — Phase 4
GnRH 2023 Treatment Timeline for Medical Study. Trial Name: NCT02357654 — Phase 4
~9 spots leftby Mar 2025
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