NCT03964779

Brief Summary

The study population will be divided into three groups:

  • Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility,
  • Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and
  • Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group. . All women will be subjected to:
  • Informed consent
  • Full history taking, including age, duration of infertility and whether primary or secondary
  • General and pelvix examination
  • Trans-vaginal ultrasonography
  • Determination of hormonal profile (FSH, LH, Estradiol, Prolactin)
  • Determination of ovulatory status
  • Determination of of tubal patency
  • Determination of presence of male factor
  • Determination of TSH and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 28, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

May 23, 2019

Last Update Submit

May 24, 2019

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • prevalence of thyroid dysfunction among infertile women

    prevalence of thyroid dysfunction (clinical or subclinical, hypothyroidism or hyperthyroidism) among infertile women

    through study completion, an average of 6 months

Study Arms (3)

Anovulatory women

40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility

Diagnostic Test: Hormonal assayDiagnostic Test: Antibody assay

Tubal factor women

40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility

Diagnostic Test: Hormonal assayDiagnostic Test: Antibody assay

male factor couple

40 women with exclusive male factor of infertility and will be used as a control group

Diagnostic Test: Hormonal assayDiagnostic Test: Antibody assay

Interventions

Hormonal assayDIAGNOSTIC_TEST

Measurement of Thyroid stimulating hormone

Also known as: TSH assay
Anovulatory womenTubal factor womenmale factor couple
Antibody assayDIAGNOSTIC_TEST

antithyroglobulin and antithyroid peroxidase

Also known as: antithyroid antibodies
Anovulatory womenTubal factor womenmale factor couple

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

120 women with infertility will be divided into three groups: * Group (A) consisting of 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility, * Group (B) consisting of 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility, and * Group (C) consisting of 40 women with exclusive male factor of infertility and will be used as a control group.

You may qualify if:

  • \- Age: 18 - 38 years
  • Infertile women whether due to functional, anatomical, male factors OR unexplained OR combined factors

You may not qualify if:

  • \- Age: below 18 and above 38 years
  • Patients with autoimmune diseases (such as lupus and rheumatoid arthritis)
  • Acute illness that require hospitalization
  • Patients on the following medications: steroids, dopamine, iodine, amiodarone, lithium, donperidone, thyroid hormone, and phenytoin.
  • Patients who work at night.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Serum Bactericidal Antibody Assay

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Serologic TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Ahmed Maged

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged

CONTACT

+201005227404prof.ahmedmaged@gmail.com

Ahmed wali

CONTACT

+201001735088ahmed.wali@kasralainy.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 28, 2019

Study Start

May 1, 2019

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

May 28, 2019

Record last verified: 2019-05

Locations

EG(1)