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临床试验/NCT03018314
NCT03018314已完成不适用

Serum Kisspeptin Levels in Infertile Women Due to Anovulatory Cycles, Unexplained Infertility or Male Subfertility: A Prospective Observational Study

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年6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
90
试验地点
1
主要终点
The relation of Kisspeptin levels and female infertility

研究概览

简要总结

The study population is comprise of 90 women those age varies between 18-38 year-old. The first group will comprise of 30 women with polycystic ovaries or anovulatory cycles, the second group will comprise of 30 women with diagnosis of unexplained infertility and the third group will comprise of 30 women those partners with male subfertility. A 2 cc blood sample for Kisspeptin analysis will be drawn from the antecubital vein from each participants. The patients will receive 50 mg clomiphene citrate at the fifth day of the menstrual period and follicular development will be measured with serial ultrasound follow up.

详细描述

The study population is comprise of 90 women those age varies between 18-38 year-old with wish of baby for at least one year despite of unprotected sexual intercourse, patent tubes confirmed in hysterosalpingography , follicle stimulating hormone levels <12 IU. The first group will comprise of 30 women with polycystic ovaries in ultrasound examination or anovulatory cycles, the second group will comprise of 30 women with diagnosis of unexplained infertility, normal menstrual periods and without known male factor infertility and the third group will comprise of 30 women those partners with sperm count between 5x106 -15x106 /mL, type A + type B motility <%32 and Kruger morphology <4%. A 2 cc blood sample for Kisspeptin analysis will be drawn from the antecubital vein from each participants and centrifuged and sera will be kept in -80 C till recruitment has been completed. Kisspeptin, E2, Progesterone, anti-mullerian hormone levels will be measured with ELISA method. The patients will receive 50 mg clomiphene citrate at the fifth day of the menstrual period and follicular development will be measured with serial ultrasound follow up.

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 38 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •ages varying between 18-38 year-old with wish of baby for at least one year despite of unprotected sexual intercourse
  • •patent tubes confirmed in hysterosalpingography
  • •follicle stimulating hormone levels <12 IU
  • •no other relevant medical history

排除标准

  • •ages other than 18-38 year-old with wish of baby for least than one year despite of unprotected sexual intercourse
  • •obstructed tubes confirmed in hysterosalpingography
  • •follicle stimulating hormone levels >12 IU
  • •history thyroid disease
  • •increased prolactin levels
  • •history of chemo/radiation therapy

结局指标

主要结局

The relation of Kisspeptin levels and female infertility

时间窗: 1 year

次要结局

  • The relation of Kisspeptin levels and follicular growth(1 year)

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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