Clinical trial NCT03964779: Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women
Official title: Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 women with infertility 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: prevalence of thyroid dysfunction among infertile women
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Professor
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References: