## Protocol Section
### Identification Module
**NCT ID:** NCT03964779

**Brief Title:** Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women

**Official Title:** Prevalence of Thyroid Dysfunction and Anti-thyroid Antibodies in Infertile Women

#### Organization Study ID Info
**ID:** 57
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2020-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2019-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2019-05-24

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-05

**Type:** ESTIMATED

**Status Verified Date:** 2019-05

#### Study First Post Date
**Date:** 2019-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2019-05-23
**Study First Submit QC Date:** 2019-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Ahmed M Maged, MD

**Investigator Title:** professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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

### Conditions Module

**Conditions:**

- Infertility, Female

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility

**Intervention Names:**

- Diagnostic Test: Hormonal assay

- Diagnostic Test: Antibody assay

**Label:** Anovulatory women

#### Arm Group 2

**Description:** 40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility

**Intervention Names:**

- Diagnostic Test: Hormonal assay

- Diagnostic Test: Antibody assay

**Label:** Tubal factor women

#### Arm Group 3

**Description:** 40 women with exclusive male factor of infertility and will be used as a control group

**Intervention Names:**

- Diagnostic Test: Hormonal assay

- Diagnostic Test: Antibody assay

**Label:** male factor couple

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Anovulatory women

- Tubal factor women

- male factor couple

**Description:** Measurement of Thyroid stimulating hormone

**Name:** Hormonal assay

**Other Names:**

- TSH assay

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Anovulatory women

- Tubal factor women

- male factor couple

**Description:** antithyroglobulin and antithyroid peroxidase

**Name:** Antibody assay

**Other Names:**

- antithyroid antibodies

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

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

**Measure:** prevalence of thyroid dysfunction among infertile women

**Time Frame:** through study completion, an average of 6 months

### Eligibility Module

**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.

**Gender Based:** True

**Maximum Age:** 40 Years

**Minimum Age:** 20 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** prof.ahmedmaged@gmail.com

**Name:** Ahmed Maged

**Phone:** +201005227404

**Role:** CONTACT

**Contact 2:**

**Email:** ahmed.wali@kasralainy.edu.eg

**Name:** Ahmed wali

**Phone:** +201001735088

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Kasr Alainy medical school

**Zip:** 12151

#### Overall Officials

**Official 1:**

**Affiliation:** Professor

**Name:** Ahmed Maged

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

### Condition Browse Module - Browse Branches

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M16718

- Name: Thyroid Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10290

- Name: Infertility

- Relevance: HIGH

- As Found: Infertility

- ID: M10291

- Name: Infertility, Female

- Relevance: HIGH

- As Found: Infertility, Female

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007246

- Term: Infertility

- ID: D000007247

- Term: Infertility, Female

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Program

- ID: M10184

- Name: Immunoglobulins

- Relevance: HIGH

- As Found: Program

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000906

- Term: Antibodies

- ID: D000007136

- Term: Immunoglobulins

### Misc Info Module

- Version Holder: 2024-05-24
