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临床试验/NCT05921877
NCT05921877招募中不适用

AMH May Not be a Good Index of Ovarian Reserve in Patients With Functional Hypothalamic Amenorrhea

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
AMH assay

研究概览

简要总结

The purpose of this study is to analyze AMH levels in patients with prolonged FHA (more than 2 years). Based on previous studies, we can assume that prolonged FHA may mimic a condition of primary hypogonadotropic hypogonadism, due to a lasting interruption of gonadotropin release. Furthermore, after the resumption of the spontaneous menstrual cycle, we will reanalyze AMH levels, which we hypothesize to find higher. If our hypotheses are confirmed correct, we could support the thesis that AMH is not a good index of ovarian reserve in patients with functional hypothalamic amenorrhea.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 34 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 15-34 years.
  • Diagnosis of functional hypothalamic amenorrhea (for at least 2 years).
  • Signature of informed consent.

排除标准

  • Polycystic ovary syndrome
  • Taking oral contraceptives in the previous three months
  • Other clinically relevant endocrinopathies
  • positive MAP-test (Medroxyprogesterone acetate test)
  • Estroprogestin replacement therapy
  • Autoimmune disorders
  • Failure to sign informed consent

结局指标

主要结局

AMH assay

时间窗: 12 months

Check serological AMH levels in patients with FHA for at least 2 years and compare them with AMH levels in healthy women.

次要结局

  • To correlate AMH levels with other parameters(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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