Dampening the Reproductive Axis With Continuous Kisspeptin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Average change in LH pulse frequency
研究概览
简要总结
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).
详细描述
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
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Receive an infusion of kisspeptin x 24 hours
-
Receive up to two kisspeptin IV boluses
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
kisspeptin
IV administration of kisspeptin 112-121; 24-hour infusion, up to 2 boluses.
干预措施: kisspeptin 112-121 (Drug)
结局指标
主要结局
Average change in LH pulse frequency
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Stephanie B. Seminara, MD
Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine
Massachusetts General Hospital