Using kisspeptin to study hormone patterns in women with PCOS
Dampening the Reproductive Axis With Continuous Kisspeptin
This study is testing how a hormone called kisspeptin affects the release of another hormone in women with polycystic ovary syndrome (PCOS).
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05971849 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of kisspeptin on luteinizing hormone (LH) secretion in individuals diagnosed with polycystic ovary syndrome (PCOS). Participants will undergo a thorough medical evaluation before receiving a continuous infusion of kisspeptin for 24 hours, during which their blood will be sampled every 10 minutes for 36 hours to assess LH secretion patterns. The study will compare baseline LH levels to those observed during kisspeptin administration to understand its impact on reproductive hormone regulation.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 with a clinical diagnosis of PCOS and a BMI between 18.5 and 35 kg/m2.
Not a fit: Patients currently using hormonal medications or with significant alcohol or drug use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for women with PCOS.
How similar studies have performed: While studies on kisspeptin are emerging, this specific approach to understanding LH patterns in PCOS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
* Ages 18-45 years * A history of clinical diagnosis of PCOS or equivalent clinical features * BMI \>18.5 and \<35 kg/m2 * Normal blood pressure (systolic BP \< 140 mm Hg, diastolic \> 90 mm Hg) * Laboratory studies: * Negative human chorionic gonadotropin (hCG) pregnancy test prior to kisspeptin administration * Hemoglobin no less than 0.5 g/dL below the lower limit of the reference range for healthy women * Not using hormonal medication or willing to complete an appropriate washout for that particular medication and its method of administration * No current or recent use of a medication 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 * No excessive alcohol consumption (\>10 drinks/week) and/or ongoing use of illicit drugs • Any current use of marijuana will be evaluated by a study medical professional to determine if it is expected to impact study participation * Not pregnant or trying to become pregnant * Not breastfeeding * No history of bilateral oophorectomy (both ovaries removed)
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie B Seminara, MD — Massachusetts General Hospital
- 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.