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GnRH Agonist

Hormone Stimulation for Reproductive Disorder

Phase 1

Waitlist Available

Led By Stephanie B Seminara, MD

Research Sponsored by Stephanie B. Seminara, MD

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 hours 8-11

Awards & highlights

Study Summary

This trial tests how infertility-related gene variants affect response to fertility-related hormone stimulation tests.

Who is the study for?

This trial is for individuals with reproductive disorders who are not on medications affecting hypothalamic function, don't use drugs or excessively drink alcohol, have no severe drug allergies, and normal blood pressure. They must also have certain blood levels within specific ranges and be enrolled in the Partners HealthCare Biobank with known genotypes.Check my eligibility

What is being tested?

The study aims to understand how people with gene variants linked to infertility respond to kisspeptin and GnRH stimulation. It will look at their baseline LH secretion patterns after administering these substances.See study design

What are the potential side effects?

Potential side effects from kisspeptin and GnRH could include allergic reactions, hormonal changes leading to mood swings or headaches, injection site discomfort, and possibly nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hours 8-11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hours 8-11

This trial's timeline: 3 weeks for screening, Varies for treatment, and hours 8-11 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Endogenous LH pulse amplitude

Kisspeptin-induced LH pulse amplitude

Trial Design

1Treatment groups

Experimental Treatment

Group I: kisspeptin, GnRHExperimental Treatment2 Interventions

IV administration of kisspeptin 112-121; one bolus. IV administration of GnRH; one bolus.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

kisspeptin 112-121

2013

Completed Phase 1

~120

GnRH

2017

Completed Phase 2

~320

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Stephanie B. Seminara, MDLead Sponsor

9 Previous Clinical Trials

1,220 Total Patients Enrolled

2 Trials studying Reproductive Disorder

626 Patients Enrolled for Reproductive Disorder

Stephanie B Seminara, MDPrincipal InvestigatorMassachusetts General Hospital

8 Previous Clinical Trials

5,486 Total Patients Enrolled

1 Trials studying Reproductive Disorder

26 Patients Enrolled for Reproductive Disorder

Media Library

Gonadotropin-releasing Hormone (GnRH) (GnRH Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05901467 — Phase 1

Reproductive Disorder Research Study Groups: kisspeptin, GnRH

Reproductive Disorder Clinical Trial 2023: Gonadotropin-releasing Hormone (GnRH) Highlights & Side Effects. Trial Name: NCT05901467 — Phase 1

Gonadotropin-releasing Hormone (GnRH) (GnRH Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05901467 — Phase 1

Frequently Asked Questions

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

Is the age criterion for inclusion in this experiment greater than 20 years?

"This trial requires that all participants be between the age of majority and 55 years old."

Answered by AI

Has the regulatory body sanctioned kisspeptin and GnRH for medical implementation?

"Since this experiment is in its initial phase, there exists only a limited amount of data concerning the safety and efficacy of kisspeptin and GnRH. Thus, our team at Power has rated it as 1 on their scale from 1 to 3."

Answered by AI

Are there any opportunities to partake in this research currently?

"According to clinicaltrials.gov, this trial has concluded recruitment and no longer needs patients. The listing was initially posted on June 30th 2023 and the last update occurred 12 days later. Luckily, there are 3 separate trials that require participants at present time."

Answered by AI

To whom does this trial offer participation opportunities?

"To be accepted into this study, individuals must have been diagnosed with a reproductive disorder and within the designated age range of 18 to 55. Approximately 120 candidates are being enrolled in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Recall by Genotype: Neuropeptide Stimulation

Stephanie B. Seminara, MD 2023. "Recall by Genotype: Neuropeptide Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05901467.

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