Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women
NCT ID: NCT03964779
Last Updated: 2019-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2019-05-31
2020-01-31
Brief Summary
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* 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
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Detailed Description
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* 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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Anovulatory women
40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility
Hormonal assay
Measurement of Thyroid stimulating hormone
Antibody assay
antithyroglobulin and antithyroid peroxidase
Tubal factor women
40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility
Hormonal assay
Measurement of Thyroid stimulating hormone
Antibody assay
antithyroglobulin and antithyroid peroxidase
male factor couple
40 women with exclusive male factor of infertility and will be used as a control group
Hormonal assay
Measurement of Thyroid stimulating hormone
Antibody assay
antithyroglobulin and antithyroid peroxidase
Interventions
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Hormonal assay
Measurement of Thyroid stimulating hormone
Antibody assay
antithyroglobulin and antithyroid peroxidase
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Infertile women whether due to functional, anatomical, male factors OR unexplained OR combined factors
Exclusion Criteria
* 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.
20 Years
40 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed M Maged, MD
professor
Principal Investigators
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Ahmed Maged
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Kasr Alainy medical school
Cairo, , Egypt
Countries
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Central Contacts
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Other Identifiers
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57
Identifier Type: -
Identifier Source: org_study_id
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