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临床试验/NCT03670758
NCT03670758Unknown不适用

Protein S Activity in Women With Unexplained Infertility

Esraa Gamal Ahmed0 个研究点目标入组 60 人开始时间: 2018年9月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
主要终点
Protein S activity

研究概览

简要总结

This study will add:

Finding out an association between Protein S activity and unexplained female infertility.

Aim:

Study hypothesis:

In women with unexplained infertility protein S activity may be low.

Study question:

In women with unexplained infertility does protein S activity low?.

This study aims to assess the activity of protein S activity in women with unexplained infertility.

Objectives:

The main objective of this study is:

To determine the prevalence of Protein S activity with unexplained female infertility and to compare its prevalence in fertile women among women attending outpatient clinics at Ain Shams University Maternity Hospital.

详细描述

  1. Type of Study: Case Control Study.
  2. Study Setting: Ain Shams University Maternity Hospital: outpatient Infertility clinic and outpatient gynecology clinic.
  3. Study Population: The study will include women with unexplained infertility (Group 1; cases) and fertile women who got pregnant and delivered at least once in the previous year with no history of recurrent abortions nor history of secondary infertility (Group 2; control).

Group 1: Will include 30 women with unexplained primary infertility; will be recruited from the outpatient infertility clinic.

Group 2; another 30 fertile women who got pregnant and delivered at least once in the previous year with no history of recurrent abortions; will recruited from outpatient gynecology clinic as control.

According to inclusion and exclusion criteria listed below.

Inclusion criteria:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 18 - 35 years old.
  • Normal husband's semen analysis, (WHO criteria):
  • Count ≥ 15 million/ml.
  • Motility: ≥ 40%
  • Morphology: ≥ 4% normal morphology.
  • Documented ovulation.
  • Normal Follicle Stimulating Hormone, Luteinizing Hormone, Thyroid Stimulating Hormone, serum prolactin.
  • Patent Fallopian tubes.
  • Normal uterine cavity.

排除标准

  • Patients aged less than 18 years or more than 35 years old.
  • Secondary infertility
  • Presence of male factor infertility
  • Anovulatory cycles.
  • Tubal block; Tubal disease is an important cause of infertility and should be specifically excluded.
  • Medical disorder that might affect pregnancy (e.g.: Diabetes, Thyroid dysfunction)
  • Patients with recurrent abortion. -

结局指标

主要结局

Protein S activity

时间窗: six months

venous blood sample

次要结局

未报告次要终点

研究者

发起方
Esraa Gamal Ahmed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Esraa Gamal Ahmed

Esraa Gamal Ahmed

Ain Shams Maternity Hospital

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