NCT02638441

Brief Summary

The aim of this study is to determine the prevalence of psychological affection in infertile egyptian women

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

December 15, 2015

Last Update Submit

December 21, 2015

Conditions

Keywords

psychological healthwomenanxietydepression

Outcome Measures

Primary Outcomes (1)

  • determination of the prevalence of depression among infertile women

    questionnaire will be used to collect qualititiative data from women

    6 months

Interventions

Detection of infertility effect on emotional status

Also known as: emotional distress of women with infertility

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InfertilityPsychological Well-BeingAnxiety DisordersDepression

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPersonal SatisfactionBehaviorMental DisordersBehavioral Symptoms

Study Officials

  • sherif a akl

    professor of obstetric and gynecology

    STUDY DIRECTOR

Central Study Contacts

ahmed m bahaa, MD

CONTACT

ahmed m bahaa

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 23, 2015

Study Start

January 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

December 23, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will share