Prevalence of Thyroid Dysfunction and Anti-thyroid Antibo... | NCT03964779

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

NCT03964779

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

May 28, 2019Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Infertility, Female

Interventions

Hormonal assay
Antibody assay

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2019Estimated

Primary Completion Date

Dec 2019Estimated

Completion Date

Jan 2020Estimated

First Submitted Date

May 23, 2019

First Submission Date that Met QC Criteria

May 24, 2019

First Posted Date

May 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2019

Last Update Posted Date

May 28, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Anovulatory women	40 infertile women with either unexplained or anovulatory infertility with/without associated male factor of infertility	Diagnostic Test: Hormonal assay Diagnostic Test: Antibody assay
Tubal factor women	40 infertile women with tubal (mechanical) factor of infertility with/without associated male factor of infertility	Diagnostic Test: Hormonal assay Diagnostic Test: Antibody assay
male factor couple	40 women with exclusive male factor of infertility and will be used as a control group	Diagnostic Test: Hormonal assay Diagnostic Test: Antibody assay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hormonal assay	Diagnostic Test	Measurement of Thyroid stimulating hormone	Anovulatory women Tubal factor women male factor couple

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

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.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Maged	Contact	+201005227404		prof.ahmedmaged@gmail.com
Ahmed wali	Contact	+201001735088		ahmed.wali@kasralainy.edu.eg

Overall Officials

Name	Affiliation	Role
Ahmed Maged	Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy medical school		Cairo		12151	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007247	Infertility, Female

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058248	Serum Bactericidal Antibody Assay

Ancestor Terms

ID	Term
D012698	Serologic Tests
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided