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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Infertility, Female

Intervention / Treatment
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* Diagnostic Test: Hormonal assay
* Diagnostic Test: Antibody assay


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anovulatory women<br>40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility | Diagnostic Test: Hormonal assay<br>* Measurement of Thyroid stimulating hormone<br>* Other names: TSH assay;Diagnostic Test: Antibody assay<br>* antithyroglobulin and antithyroid peroxidase<br>* Other names: antithyroid antibodies;|
| Tubal factor women<br>40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility | Diagnostic Test: Hormonal assay<br>* Measurement of Thyroid stimulating hormone<br>* Other names: TSH assay;Diagnostic Test: Antibody assay<br>* antithyroglobulin and antithyroid peroxidase<br>* Other names: antithyroid antibodies;|
| male factor couple<br>40 women with exclusive male factor of infertility and will be used as a control group | Diagnostic Test: Hormonal assay<br>* Measurement of Thyroid stimulating hormone<br>* Other names: TSH assay;Diagnostic Test: Antibody assay<br>* antithyroglobulin and antithyroid peroxidase<br>* Other names: antithyroid antibodies;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |