Psychological Profile of Women With Infertility in Egypt:... | NCT02638441

Studies
Psychological Profile of Women With Infertility in Egypt: A Comparative Study

NCT02638441

Sponsor

Ain Shams Maternity Hospital

Status

Unknown status

Last Update Posted

Dec 23, 2015Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Infertility

Interventions

hospital anxiety and depression scale

Countries

Not provided

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

Dec 2015

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

Jan 2016

Primary Completion Date

Jul 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Dec 15, 2015

First Submission Date that Met QC Criteria

Dec 21, 2015

First Posted Date

Dec 23, 2015Estimated

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

Dec 21, 2015

Last Update Posted Date

Dec 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

400Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hospital anxiety and depression scale	Other	Detection of infertility effect on emotional status		emotional distress of women with infertility

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
determination of the prevalence of depression among infertile women	questionnaire will be used to collect qualititiative data from women	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Control group:

Pregnant women.
At least one live birth.
Age group 20-40 years.

Clinical group:

Infertile women either primary or secondary according to (WHO,2013).
Age group 20-40ys.
Different levels of education.
Different methods of treatment of infertility (medical or IVF)
Half of them from rural area the other half from urban area.

Exclusion Criteria:

Male factor of infertility.
The women with psychiatric disorders.
The women with physical and medical disorders.
The women whose current pregnancy has any problems (e.g. growth retardation, macrosomia, placenta previa, threatened abortion, or preterm labour).
The women with history of intrauterine fetal death.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

This study will be conducted at the department of Obstetrics and Gynecology of Ain shams university and Zagazig university and some private centres for the treatment of infertility. It will include 400 women, divided into two groups (control group and clinical group) starting from January 2016.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ahmed m bahaa, MD	Contact	01099517965	02	hindlaban@yahoo.com
ahmed m bahaa	Contact	01099517965	02	hindlaban@yahoo.com

Overall Officials

Name	Affiliation	Role
sherif a akl	professor of obstetric and gynecology	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility
D000092862	Psychological Well-Being
D001008	Anxiety Disorders
D003863	Depression

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D010549	Personal Satisfaction
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C018209	4-amino-4'-hydroxylaminodiphenylsulfone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided