Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease

Purpose

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.

Conditions

  • Reproductive Disorder
  • Neurodegeneration
  • SARS-CoV 2
  • Long COVID

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Female (ages 18-45 years) or Male (ages 18-60 years) - 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 or the interpretation of results - Active use of illicit drugs (not including marijuana) - For women, - Pregnant - Trying to become pregnant during protocol participation - Breast feeding - Surgical or natural menopause

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Kisspeptin administration 		Single bolus of kisspeptin
  • Drug: Kisspeptin 112-121
    Single bolus of kisspeptin
    Other names:
    • Metastin 45-54

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Study Coordinator
617-643-2308
MGHKisspeptinResearch@partners.org

More Details

Status
Recruiting
Sponsor
Stephanie B. Seminara, MD

Study Contact

Study Coordinator
617-643-2308
MGHKisspeptinResearch@partners.org

Detailed Description

Delivery of Interventions: - Administration of a single kisspeptin bolus in a dosing range of 0.313 - 13.19 μg/kg - Blood sampling before and after administration of kisspeptin (two timepoints total)