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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female

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 Type: Observational
• Enrollment (Actual): 88

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

female healthy participants who attend the outpatient clinic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
unexplained infertility patients; 44 patients diagnosed to have unexplained infertility
Fertile women; 44 fertile women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Helicobacter Pylori IgG Assay in Serum	calculation of quantitative Helicobacter pylori IgG assay in serum	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 8, 2016
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: April 10, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: unexplained infertility

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided