Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease

NCT ID: NCT07224490

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2030-05-31

Brief Summary

The objective of this protocol is to use a case-control paradigm to compare the response to an intravenous administration of kisspeptin in individuals with and without post-covid-19 syndrome. The study subjects will receive a single bolus of kisspeptin.

This study will utilize the technique of frequent blood sampling (q10 minutes) to provide detailed neuroendocrine characterization of endogenous LH secretion before and after kisspeptin administration. This frequency of blood sampling is required to define the features of LH pulses.

Detailed Description

Delivery of Interventions:

• 1-2 hours of q10 minute blood sampling
• Administration of a single kisspeptin bolus in a dosing range of 0.313 - 13.19 μg/kg

Conditions

Reproductive Disorder; Neurodegeneration; SARS-CoV 2

Keywords

Reproductive disorder; Neurodegeneration; SARS-CoV 2; Kisspeptin

Study Design

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

Study Groups

Kisspeptin administration

Single bolus of kisspeptin

Group Type: EXPERIMENTAL

Kisspeptin 112-121

Intervention Type: DRUG

Single bolus of kisspeptin

Interventions

Kisspeptin 112-121

Single bolus of kisspeptin

Intervention Type: DRUG

Other Intervention Names

Metastin 45-54

Eligibility Criteria

Inclusion Criteria

• Female (ages 18-45 years) or Male (ages 18-60 years)
• Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)
• Hemoglobin no less than 0.5 g/dL below the lower limit of the sex specific reference range
• No current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration
• For women, negative serum hCG pregnancy test
• For cases, diagnosis of post-covid-19 syndrome
• For controls, history of prior covid infection but no diagnosis of post-covid-19 syndrome

Exclusion Criteria

• Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol
• Excessive alcohol consumption (>10 drinks/week)
• Active use of illicit drugs
• For women,
• Pregnant
• Trying to become pregnant during protocol participation
• Breast feeding
• History of any of the following: bilateral oophorectomy (ovaries were removed), breast cancer, thromboembolic disease, coronary artery disease, stroke, thrombophilic disorders, or undiagnosed abnormal genital bleeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

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

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Study Coordinator

Role: CONTACT

Phone: 617-643-2308

Email: MGHKisspeptinResearch@partners.org

Facility Contacts

Study Coordinator

Role: primary

Other Identifiers

R37HD043341

Identifier Type: NIH

Identifier Source: secondary_id

View Link

565179

Identifier Type: -

Identifier Source: org_study_id