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| ID | Type | Description | Link |
|---|---|---|---|
| R37HD043341 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.
Assignment: All study subjects will undergo the same interventions.
Delivery of Interventions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kisspeptin pump | Experimental | SC administration of kisspeptin for two weeks (pulsatile) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kisspeptin 112-121 | Drug | SC administration of kisspeptin for two weeks (pulsatile, approximately every 90 minutes) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of luteinizing hormone (LH) pulse amplitude | Difference in LH amplitude on the first day of kisspeptin administration vs the last day of kisspeptin administration | 2 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants that achieve development of a mature follicle or show evidence of ovulation | Mature follicle achievement is defined as evidence of a follicle with maximum diameter ≥18 mm. Evidence of ovulation is defined as detection of a corpus luteum on ultrasound in combination with elevated progesterone level. | 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Contact | 617-643-2308 | MGHKisspeptinResearch@partners.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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