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

• Sponsor: Cairo University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03964779
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 14.9

Study Details

Study Description

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	Phase
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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women
• Anticipated Study Start Date: May 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. prevalence of thyroid dysfunction among infertile women [through study completion, an average of 6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasr Alainy medical school	Cairo		Egypt	12151

Sponsors and Collaborators

• Cairo University

Investigators

• Principal Investigator: Ahmed Maged, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed M Maged, MD, professor, Cairo University
• ClinicalTrials.gov Identifier: NCT03964779
• Other Study ID Numbers: 57
• First Posted: May 28, 2019
• Last Update Posted: May 28, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Infertility, Female; Antibodies; Immunoglobulins

Study Results

No Results Posted as of May 28, 2019