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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03964779
• Other study ID #: 57
• Status: Not yet recruiting
• Start date: May 2019
• Est. completion date: January 2020

Study information

• Verified date: May 2019
• Source: Cairo University
• Contact: Ahmed Maged
• Phone: +201005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Diagnostic Test:
• Hormonal assay
Measurement of Thyroid stimulating hormone
• Antibody assay
antithyroglobulin and antithyroid peroxidase

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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