NCT02684604

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
2 months until next milestone

Results Posted

Study results publicly available

April 4, 2016

Completed
Last Updated

May 16, 2016

Status Verified

April 1, 2016

Enrollment Period

8 months

First QC Date

February 8, 2016

Results QC Date

March 3, 2016

Last Update Submit

April 10, 2016

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • Quantitative Helicobacter Pylori IgG Assay in Serum

    calculation of quantitative Helicobacter pylori IgG assay in serum

    24 hours

Study Arms (2)

unexplained infertility patients

44 patients diagnosed to have unexplained infertility

Fertile women

44 fertile women

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

female healthy participants who attend the outpatient clinic

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Results Point of Contact

Title
amr ahmed mahmoud riad
Organization
Ain Shams Maternity hospital
amr.riad@med.asu.edu.eg
01005347179

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 18, 2016

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

May 16, 2016

Results First Posted

April 4, 2016

Record last verified: 2016-04