Dampening the Reproductive Axis With Continuous Kisspeptin
- Conditions
- Reproductive DisorderPCOSPolycystic Ovary Syndrome
- Interventions
- Registration Number
- NCT05971849
- Lead Sponsor
- Stephanie B. Seminara, MD
- Brief Summary
The goal of this study is to assess response to kisspeptin as well as the baseline patterns of luteinizing hormone (LH) secretion in individuals with polycystic ovarian syndrome (PCOS).
- Detailed Description
Assignment: All study subjects will undergo the same interventions. Baseline LH secretion patterns of individuals with PCOS will be compared to their LH secretion patterns while receiving a kisspeptin infusion.
Delivery of Interventions:
* Prior to the inpatient study visit, the subjects will undergo a review of their medical history, physical exam, and screening laboratories.
* On the day of the study, the subjects will have an intravenous (IV) line placed and
* Undergo up to q10 min blood sampling x 36 hours
* Receive an infusion of kisspeptin x 24 hours
* Receive up to two kisspeptin IV boluses
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description kisspeptin kisspeptin 112-121 IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses.
- Primary Outcome Measures
Name Time Method Average change in LH pulse frequency 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion Average change in LH pulse frequency before and during kisspeptin infusion
Average change in LH pulse amplitude 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion Average change in LH pulse amplitude before and during kisspeptin infusion
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States