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

Completed

• Conditions: Infertility, Female

• Registration Number: NCT02684604
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-18
• Results First Submitted: 2016-03-03
• Results First Submitted QC: 2016-03-03
• Status Verified: 2016-04
• Results First Posted: 2016-04-04
• Last Update Submitted: 2016-04-10
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

1. regular cycles.
2. normal thyroid function, prolactin and androgen levels.
3. normal semen analysis of the partner.
4. normal hysterosalpingography.
5. normal transvaginal ultrasound examination.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative Helicobacter Pylori IgG Assay in Serum	24 hours	calculation of quantitative Helicobacter pylori IgG assay in serum