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

NCT ID: NCT03964779

Last Updated: 2019-05-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-31

Study Completion Date

2020-01-31

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

Conditions

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Infertility, Female

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Measurement of Thyroid stimulating hormone

Antibody assay

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Measurement of Thyroid stimulating hormone

Antibody assay

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Measurement of Thyroid stimulating hormone

Antibody assay

Intervention Type DIAGNOSTIC_TEST

antithyroglobulin and antithyroid peroxidase

Interventions

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Hormonal assay

Measurement of Thyroid stimulating hormone

Intervention Type DIAGNOSTIC_TEST

Antibody assay

antithyroglobulin and antithyroid peroxidase

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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TSH assay antithyroid antibodies

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed Maged

Role: CONTACT

+201005227404

Ahmed wali

Role: CONTACT

+201001735088

Other Identifiers

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57

Identifier Type: -

Identifier Source: org_study_id

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