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

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ClinicalTrials.gov Identifier: NCT03964779
Recruitment Status : Not yet recruiting
First Posted : May 28, 2019
Last Update Posted : May 28, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed M Maged, MD, Cairo University

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

Condition or disease Intervention/treatment
Infertility, Female Diagnostic Test: Hormonal assay Diagnostic Test: Antibody assay

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

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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 Name: TSH assay

Diagnostic Test: Antibody assay
antithyroglobulin and antithyroid peroxidase
Other Name: 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 Name: TSH assay

Diagnostic Test: Antibody assay
antithyroglobulin and antithyroid peroxidase
Other Name: 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 Name: TSH assay

Diagnostic Test: Antibody assay
antithyroglobulin and antithyroid peroxidase
Other Name: antithyroid antibodies




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964779


Contacts
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Contact: Ahmed Maged +201005227404 prof.ahmedmaged@gmail.com
Contact: Ahmed wali +201001735088 ahmed.wali@kasralainy.edu.eg

Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged Professor
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Responsible Party: Ahmed M Maged, MD, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03964779    
Other Study ID Numbers: 57
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs