Psychiatric Disorders With Prolonged Infertility | NCT03569215

Studies
Psychiatric Disorders With Prolonged Infertility

NCT03569215

Sponsor

Tanta University

Status

Completed

Last Update Posted

Aug 3, 2023Actual

Enrollment

324Actual

Phase

Not provided

Conditions

Psychiatric Disorder
Invitro Fertilization /Intracytoplasmic Spem Injection Failure

Interventions

Questionnaire

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Jun 14, 2018

First Submission Date that Met QC Criteria

Jun 14, 2018

First Posted Date

Jun 26, 2018Actual

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

Aug 1, 2023

Last Update Posted Date

Aug 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Psychiatric disorders in women with prolonged infertility with or without IVF/ICSI failure will be included then a questionnaire will be applied plus psychiatric examinatins

Detailed Description

All patients will be recruited from both psychiatry and obstetrics and gynecology departments. Referred cases from gynecologists and Assisted reproductive technologies centers were also included.

Inclusion criteria:

Infertile couples Infertility >= 5 years invitro fertilization /intracytoplasmic spem injection failure for group 1 and not included for group 2

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

324Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IVF/ICSI failure		These patients had prolonged infertility with one or more failure of IVF/ICSI cycles	Behavioral: Questionnaire
Prolonged infertility only		These patients had prolonged infertility without any trials of IVF/ICSI cycles	Behavioral: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Behavioral	All included patients will be exposed to questionnaires and psychiatric diagnostic tests	IVF/ICSI failure Prolonged infertility only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence and types of psychiatric disorders among prolonged infertility couples	Incidence and most common types of psychiatric disorders	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infertile women
prolonged infertility ≥ 5 years
Failed invitro fertilization /intracytoplasmic spem injection for group 1
not bearing any children
accepting to share in the study.

Exclusion Criteria:

patients with diagnosed psychiatric or neurologic disorders
patients with diabetes mellitus or any anatomical defects in genital tract
patients who didn't complete their questionnaires.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

based on ID presentation

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All infertile women with prolonged infertility with or without history of IVF/ICSI failure

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayman Dawood, MD	Lecturer at Tanta University	Study Director
Reham Amer, MD	Lecturer at Tanta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reham Amer		Tanta			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual participant data is secret as privacy and security of data is a must

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001523	Mental Disorders

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided