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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684604
• Other study ID #: unexplained infertility
• Status: Completed
• Phase: N/A
• First received: February 8, 2016
• Last updated: February 17, 2016
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 immunode?ciency virus (HIV), TORCH, Chlamydia trachomatis and Mycoplasma.

3. presence of anti-sperm antibodies in serum.

4. Male factor infertility.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of anti-Helicobacter Pylori IgG	Presence of anti-Helicobacter Pylori IgG in serum in both groups	24 hours	Yes