NCT03569215

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

4.5 years

First QC Date

June 14, 2018

Last Update Submit

August 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence and types of psychiatric disorders among prolonged infertility couples

    Incidence and most common types of psychiatric disorders

    6 months

Study Arms (2)

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

QuestionnaireBEHAVIORAL

All included patients will be exposed to questionnaires and psychiatric diagnostic tests

Also known as: Psychiatric diagnostic tests
IVF/ICSI failureProlonged infertility only

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbased on ID presentation
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reham Amer

Tanta, Egypt

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ayman Dawood, MD

    Lecturer at Tanta University

    STUDY DIRECTOR
  • Reham Amer, MD

    Lecturer at Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 14, 2018

First Posted

June 26, 2018

Study Start

July 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

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

Locations