Reproductive Disorder, PCOS, Polycystic Ovary Syndrome
Conditions
Keywords
reproductive disorders, kisspeptin, PCOS
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
Interventions
IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin
Sponsors
Stephanie B. Seminara, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed