Clinical trial NCT05971849: Dampening the Reproductive Axis With Continuous Kisspeptin
Official title: Dampening the Reproductive Axis With Continuous Kisspeptin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Reproductive Disorder
PCOS
Polycystic Ovary Syndrome
Keywords: reproductive disorders
kisspeptin
PCOS
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility 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)

Primary outcomes:
measure: Average change in LH pulse frequency
timeFrame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
measure: Average change in LH pulse amplitude
timeFrame: 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Stephanie B Seminara, MD
role: PRINCIPAL_INVESTIGATOR
References: