Recall by Genotype: Neuropeptide Stimulation

NCT ID: NCT05901467

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2024-05-29

Brief Summary

The objective of this protocol is to assess response to kisspeptin and gonadotropin-releasing hormone (GnRH) stimulation testing as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals who carry variants in genes related to infertility.

Detailed Description

Assignment: All study subjects will undergo the same interventions. Individuals at high risk for infertility (i.e., carry variants in genes related to infertility) will be compared to controls (i.e., those who do not carry variants in genes related to infertility).

Delivery of Interventions:

• Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.
• On the day of the study, the subjects will have an intravenous (IV) line placed and

• Undergo up to q10 min blood sampling x 12 hours
• Receive a single kisspeptin IV bolus at hour 8
• Receive a single GnRH IV bolus at hour 11

Conditions

Reproductive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

kisspeptin, GnRH

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

Group Type: EXPERIMENTAL

kisspeptin 112-121

Intervention Type: DRUG

One IV bolus of kisspeptin 112-121

GnRH

Intervention Type: DRUG

One IV bolus of gonadotropin-releasing hormone

Interventions

kisspeptin 112-121

One IV bolus of kisspeptin 112-121

Intervention Type: DRUG

GnRH

One IV bolus of gonadotropin-releasing hormone

Intervention Type: DRUG

Other Intervention Names

metastin 45-54; gonadotropin-releasing hormone

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stephanie B. Seminara, MD

OTHER

Sponsor Role: lead

Responsible Party

Stephanie B. Seminara, MD

Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephanie B Seminara, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P50HD104224

Identifier Type: NIH

Identifier Source: secondary_id

View Link

326733

Identifier Type: -

Identifier Source: org_study_id