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临床试验/NCT02684604
NCT02684604已完成不适用

Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility

Ain Shams Maternity Hospital0 个研究点目标入组 88 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
主要终点
Quantitative Helicobacter Pylori IgG Assay in Serum

研究概览

简要总结

Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing that with it's prevalence in fertile women.

详细描述

Unexplained infertility was diagnosed according to standard World Health Organization (WHO) criteria. All women in the study had hormonal assessment to evaluate their ovulatory cycles, thyroid function, circulating prolactin and androgen levels. The ovarian reserve was checked by measurement of serum FSH and an antral follicle count on the third day of the menstrual cycle. Screening for infertility also included transvaginal ultrasound and hysterosalpingography, to exclude possible uterine malformations or pathologies, and to assess the patency of the fallopian tubes. Male factor infertility was excluded in all couples, according to standard WHO semen analysis.

Following admission, all patients underwent complete clinical examination and detailed medical history was obtained.

A venous sample was collected to test serum for HP IgG seropositivity by enzyme linked immunoassay for HELICOBACTOR PYLORI IgG (ENZYME IMMUNOASSAY TEST KIT).

研究设计

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

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

  • regular cycles.
  • normal thyroid function, prolactin and androgen levels.
  • normal semen analysis of the partner.
  • normal hysterosalpingography.
  • normal transvaginal ultrasound examination.

排除标准

  • possible uterine malformations or pathologies.
  • presence of infections, including hepatitis, human immunodeficiency virus (HIV), TORCH, Chlamydia trachomatis and Mycoplasma.
  • presence of anti-sperm antibodies in serum.
  • Male factor infertility.

结局指标

主要结局

Quantitative Helicobacter Pylori IgG Assay in Serum

时间窗: 24 hours

calculation of quantitative Helicobacter pylori IgG assay in serum

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Ahmed Mahmoud Riad

Lecturer of obstetrics and gynecology

Ain Shams Maternity Hospital

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