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Gene study probes infertility hormone clues

NCT ID NCT05901467

Knowledge-focused Sponsor: Stephanie B. Seminara, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how the body responds to certain hormones (kisspeptin and GnRH) in people who carry gene variants linked to infertility. Researchers measured natural hormone patterns and responses to stimulation in 16 participants. The goal was to better understand reproductive disorders, not to provide treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

Oct 2023

Finished

May 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * No prescription medications that could interfere with hypothalamic reproductive function * No illicit drug use * No excessive alcohol consumption (more than 10 drinks/week) * No history of an allergic medication reaction requiring emergency medical care * Normal blood pressure reading (systolic blood pressure \< 140 mm Hg, diastolic \< 90 mm Hg) * White blood cell, platelet counts, prolactin, and thyroid-stimulating hormone (TSH) between 90% of the lower limit and 110% of the upper limit of the reference range * Normal hemoglobin * Blood urea nitrogen (BUN), creatinine not elevated * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) within 3 times upper limit of normal * Enrolled in the Partners HealthCare Biobank and genotypically characterized * For women * No oral contraceptives for at least 1 month * No contraceptive implants for at least 3 months * Not breastfeeding and not pregnant * Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration)

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Conditions

The condition(s) this trial relates to.

infertility disorder reproductive system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Reproductive disorder

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.