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OpenTrials
Completed

NCT Number: NCT02684604

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

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

Completed

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Quantitative Helicobacter Pylori IgG Assay in Serum

    Time frame: 24 hours

    calculation of quantitative Helicobacter pylori IgG assay in serum

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2016
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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