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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 9 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Live birth per transfer

Secondary outcome measures

clinical pregnancy

implantation rates

rates of OHSS

Side effects data

From 2009 Phase 2 trial • 36 Patients • NCT00586898

22%

Hyperglycemia

19%

Hot Flashes

17%

Dyspnea

14%

Hyperkalemia

SGPT (ALT)

Hypoglycemia

Pneumonitis

Cardiovascular, other

100%

80%

60%

40%

20%

Study treatment Arm

All Participants

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

~320

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently participating in this clinical experiment?

"Affirmative. According to the figures on clinicaltrials.gov, this research effort is actively trying to gather 350 participants from a single site. The trial was first listed 11/1/2015 and most recently updated 5/25/2022."

Answered by AI

To what extent is GnRH a safe and viable therapeutic option?

"There is overwhelming evidence in favor of GnRH's safety, so it earned a score of 3."

Answered by AI

Is this trial currently seeking participants?

"According to clinicaltrials.gov, this particular medical trial is in need of participants at the present time. This study was first made available on November 1st 2015 and has undergone its most recent update on May 25th 2022."

Answered by AI

Who makes a suitable candidate for participating in this medical experiment?

"This trial aims to recruit 350 people between 18 and 40 who are struggling with infertility. To be considered, patients must meet these criteria."

Answered by AI

What other research has been done on GnRH's efficacy in a clinical setting?

"Currently, there are 46 active GnRH-related clinical trials with 10 in their third phase. The majority of the studies for this hormone can be found at sites in Chicago, Illinois; however, across the entire US there is a total of 1321 trial centres conducting research."

Answered by AI

Does the age bracket for this research include individuals over 40?

"This medical trial is only available to applicants aged between 18-40. Patients younger than 18 have 19 separate studies they can participate in, while those over 65 may join 59 different trials."

Answered by AI

Who else is applying?

What state do they live in?

New Jersey

New York

Pennsylvania

Other

How old are they?

18 - 65

What site did they apply to?

University Reproductive Associates

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I've tried fertility treatments but I end up finding out that it didn't work because my tubes are tied so I would like to try ivf.

PatientReceived 2+ prior treatments

Last year in May I had to have my tubes removed and the doctor told me and my husband the only way we could have a child was through IVF.

PatientReceived no prior treatments

I was diagnosed with infertility six years ego. Since then, I had multiple unsuccessful attempts of insemination at Kaiser Permanente Hospital in Downey, CA. One month ago I had an attempt of IVF at a clinic in Ukraine (my USA insurance does not cover IVF), but only two follicles were retrieved and there was only one egg. After ICSI, egg did not divide. My big dream is to become a mom and I hope this study will help me.

PatientReceived 2+ prior treatments