GnRH for Infertility

University Reproductive Associates, Hasbrouck Heights, NJ

GnRH +1 morePhase 4RecruitingLed by Peter G McGovern, MDResearch 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

Must not have

Be younger than 18 years old

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up9 months

Awards & highlights

Approved for 5 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

All Individual Drugs Already Approved

Study Summary

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

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

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

Gonadorelin

FDA approved

Do I qualify?Apply below to find out

Find a site

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 Investigator

Rutgers 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