Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease

Not Applicable

Not yet recruiting

• Conditions: Reproductive Disorder; Neurodegeneration; SARS-CoV 2
• Interventions: Drug: Kisspeptin 112-121

• Registration Number: NCT07224490
• Lead Sponsor: Stephanie B. Seminara, MD

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

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-03
• Study First Submitted QC: 2025-11-03
• Last Update Submitted: 2025-11-03
• Study First Posted: 2025-11-04
• Last Update Posted: 2025-11-04
• Study Start: 2025-12-01
• Primary Completion: 2030-05
• Study Completion: 2030-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kisspeptin administration	Kisspeptin 112-121	Single bolus of kisspeptin

Primary Outcome Measures

Name	Time	Method
Difference in mean luteinizing hormone (LH) amplitude between cases and controls	Day of study visit (one to two hours)	Difference between cases and controls of mean LH amplitude in response to kisspeptin

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States