Kisspeptin to Quantify GnRH Neuronal Function in Health and Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Kisspeptin 112-121.
- Who it may be relevant to
- Registry conditions: Reproductive Disorder, Neurodegeneration, SARS-CoV 2, Long COVID. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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)
Interventions
- Drug Kisspeptin 112-121
Single bolus of kisspeptin
Primary outcome measures
- Difference in mean luteinizing hormone (LH) amplitude between cases and controls [Time frame: Day of study visit (one to two hours)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07224490 · 565179 · R37HD043341