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临床试验/NCT02438735
NCT02438735已完成不适用

The Effect Of The Presence Of Endometriomas On Ovarian Reserve

Uludag University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Change in Serum Anti- mullerian hormone (AMH) level

研究概览

简要总结

Prior studies have shown surgical excision of endometriomas are associated with a decline in ovarian reserve as assessed by serum anti-Mullerian Hormone (AMH) levels. However, the natural history of serum AMH levels in the presence of untreated endometriomas are unknown. Purpose of this study is to determine whether the presence of endometriomas cause a faster decline in serum AMH levels than in healthy women over a six months period.

详细描述

The study is a prospective cohort study. Women diagnosed with endometriomas by transvaginal or transabdominal ultrasound or MRI will be recruited from a tertiary care endometriosis clinic. Age matched healthy controls will be recruited from the staff of the same hospital. A priorly published historical group of women who underwent endometrioma excision will be a second comparator.

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
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Reproductive age
  • Endometrioma without indication for surgery or treatment with combined contraceptive, progestin or other hormonal intervention.

排除标准

  • Menstrual cycle irregularity
  • Polycystic ovarian syndrome
  • Women who were pregnant or contemplating pregnancy in the next six months
  • History of ovarian surgery
  • Using medication which could affect ovarian function during six months before recruitment
  • Indication for surgical excision

结局指标

主要结局

Change in Serum Anti- mullerian hormone (AMH) level

时间窗: at recruitment and six months later

次要结局

未报告次要终点

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

GÜRKAN UNCU,PROF. MD

prof.md

Uludag University

研究点 (1)

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