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

Conditions
Infertility, Female
Interventions
Diagnostic Test: Hormonal assay
Diagnostic Test: Antibody assay
Registration Number
NCT03964779
Lead Sponsor
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

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

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
120
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Tubal factor womenHormonal assay40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility
male factor coupleAntibody assay40 women with exclusive male factor of infertility and will be used as a control group
Anovulatory womenAntibody assay40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility
Tubal factor womenAntibody assay40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility
Anovulatory womenHormonal assay40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility
male factor coupleHormonal assay40 women with exclusive male factor of infertility and will be used as a control group
Primary Outcome Measures
NameTimeMethod
prevalence of thyroid dysfunction among infertile womenthrough study completion, an average of 6 months

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Kasr Alainy medical school

🇪🇬

Cairo, Egypt

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