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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| kisspeptin | Experimental | IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kisspeptin 112-121 | Drug | IV infusion of kisspeptin 112-121 x 24 hours; up to two IV boluses of kisspeptin |
|
| 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 |
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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:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie B Seminara, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |