Kisspeptin to measure GnRH neuron function in people with and without post-COVID-19 syndrome
Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease
We will give one intravenous kisspeptin dose and take frequent blood samples to see if people with post-COVID-19 syndrome have different GnRH/LH hormone responses than people who had COVID but did not develop long COVID.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07224490 on ClinicalTrials.gov |
What this trial studies
This single-site, Phase 1 case-control protocol gives a single IV bolus of kisspeptin (0.313–13.19 μg/kg) to people with post-COVID-19 syndrome and to controls who had prior COVID infection without ongoing post-COVID symptoms. Participants undergo 1–2 hours of blood sampling every 10 minutes to define LH pulse characteristics before and after kisspeptin administration. The study compares neuroendocrine responses between groups to quantify GnRH neuronal function with high temporal resolution. Eligible adults include females 18–45 and males 18–60 who meet blood pressure and hemoglobin criteria and are not taking (or can wash out) medications that affect the reproductive axis.
Who should consider this trial
Good fit: Ideal candidates are adults who had prior COVID infection—either diagnosed with post-COVID-19 syndrome (cases) or recovered without post-COVID-19 syndrome (controls)—women aged 18–45 and men aged 18–60 with normal blood pressure and acceptable hemoglobin who are not on or can stop medications that affect the reproductive axis.
Not a fit: People who are pregnant, actively using illicit drugs, drinking heavily, have unstable medical or psychiatric conditions, or cannot discontinue medications that affect the reproductive axis are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could show whether post-COVID-19 syndrome alters GnRH/LH signaling and help guide diagnosis and future treatments for reproductive symptoms after COVID.
How similar studies have performed: Kisspeptin has been used in prior human studies to provoke GnRH/LH responses and map reproductive neuroendocrine function, but using it specifically to study post-COVID-19 syndrome is a novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Study Coordinator
- Email: MGHKisspeptinResearch@partners.org
- Phone: 617-643-2308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.