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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05971836
Other study ID # 2020P000762
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 21, 2021
Est. completion date March 2026

Study information

Verified date July 2023
Source Massachusetts General Hospital
Contact Study Coordinator
Phone 617-643-2308
Email reproendogenetics@partners.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to learn more about the genes that control puberty and reproduction in humans.


Description:

All study subjects will undergo the same activities. Subjects will provide up to five tubes of blood for genetic analysis, complete a smell test, and answer questions about their health and family history.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility Participants must belong to one of the following categories: - Failure to go through a normal, age-appropriate, spontaneous puberty and low sex steroid levels in the setting of low/normal gonadotropins or, - Abnormally early development of puberty or, - Normal puberty with subsequent development of low gonadotropin levels or, - Evidence of a reproductive disorder with high gonadotropin levels or, - Pre-pubertal individuals with features suggestive of hypogonadotropic hypogonadism or, - Affected and unaffected family members of individuals that fit criteria above

Study Design


Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Stephanie B. Seminara, MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Genetic variation Identification of one or more genetic variations related to reproductive disorders Day 1
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