Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women

May 24, 2019 updated by: Ahmed M Maged, MD, Cairo University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 (by previous documented history of induction of ovulation OR previous ultrasonography OR previous estimation midluteal serum progesterone, etc …)
  • Determination of of tubal patency (by previous hysterosalpingiography or laparoscopy)
  • Determination of presence of male factor (by seminal fluid analysis)
  • Determination of TSH and antithyroid antibodies (antithyroglobulin and antithyroid peroxidase) blood levels

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12151
        • Kasr Alainy Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • - 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anovulatory women
40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility
Diagnostic test: Hormonal assay
Measurement of Thyroid stimulating hormone
Other Names:
  • TSH assay
Diagnostic test: Antibody assay
antithyroglobulin and antithyroid peroxidase
Other Names:
  • antithyroid antibodies
Tubal factor women
40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility
Diagnostic test: Hormonal assay
Measurement of Thyroid stimulating hormone
Other Names:
  • TSH assay
Diagnostic test: Antibody assay
antithyroglobulin and antithyroid peroxidase
Other Names:
  • antithyroid antibodies
male factor couple
40 women with exclusive male factor of infertility and will be used as a control group
Diagnostic test: Hormonal assay
Measurement of Thyroid stimulating hormone
Other Names:
  • TSH assay
Diagnostic test: Antibody assay
antithyroglobulin and antithyroid peroxidase
Other Names:
  • antithyroid antibodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of thyroid dysfunction among infertile women
Time Frame: through study completion, an average of 6 months
prevalence of thyroid dysfunction (clinical or subclinical, hypothyroidism or hyperthyroidism) among infertile women
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 28, 2019

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 24, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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