Dampening the Reproductive Axis With Continuous Kisspeptin

Study Overview
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Brief Summary
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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
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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 Receive up to one gonadotropin-releasing hormone (GnRH) IV bolus

Official Title
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Dampening the Reproductive Axis With Continuous Kisspeptin

Conditions
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Reproductive Disorder, PCOS, Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: kisspeptin 112-121
* Drug: GnRH


Participation Criteria
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Eligibility Criteria
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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 history of a medication reaction that required emergency medical care 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kisspeptin, GnRH<br>IV administration of kisspeptin 112-121; 24-hour infusion. IV administration of GnRH; up to one bolus. | Drug: kisspeptin 112-121<br>* IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin<br>* Other names: metastin 45-54;Drug: GnRH<br>* Up to one IV bolus of GnRH<br>* Other names: gonadotropin-releasing hormone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average change in LH pulse frequency | Average change in LH pulse frequency before and during kisspeptin infusion | 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion | 
| Average change in LH pulse amplitude | Average change in LH pulse amplitude before and during kisspeptin infusion | 6 hours prior to kisspeptin infusion compared to the final 6 hours of kisspeptin infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, reproductive disorders, kisspeptin, GnRH