NCT05881044

Brief Summary

To asses psychiatric impacts of In vitro fertilization.

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
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

March 24, 2023

Last Update Submit

May 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement of depression in couples with IVF .

    Measurement of psychiatric aspects in patients who perform or plan to perform in vitro fertilization by psychometric scales for measurement of depression such as The Hamilton Depression Rating Scale (HAM-D or HDRS) depression scale. * Scores below 7 generally represent the absence or remission of depression. * Scores between 7-17 represent mild depression * Scores between 18-24 represent moderate depression * Scores 25 and above represent severe depression

    Baseline

Interventions

1. Psychiatric interview which include personal identification, present history, past history and family history 2. Complete physical and Neurological Examination. 3. Mini Neuropsychiatric Interview scale. (MINI): to diagnosis psychiatric disorders 4. Symptom checklist 90(SCL 90) 5. Quality of life questionnaire. 6. Hamilton Depression scale. 7. Hamilton Anxiety scale. 8. Socioeconomic scale (A.El.Gilany,A.El.Wehady,and M.EL.Wasify)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

1. Psychiatric interview which include personal identification, present history, past history and family history 2. Complete physical and Neurological Examination. 3. Mini Neuropsychiatric Interview scale. (MINI): to diagnosis psychiatric disorders 4. Symptom checklist 90(SCL 90) 5. Quality of life questionnaire. 6. Hamilton Depression scale. 7. Hamilton Anxiety scale. 8. Socioeconomic scale (A.El.Gilany,A.El.Wehady,and M.EL.Wasify)

You may qualify if:

  • Couples who perform or planning or failed to perform in vitro fertilization.
  • Age from 18y To 40y .

You may not qualify if:

  • Couples with any Psychiatric disorders prior to marriage.
  • Couples with any physical or mental handcapes.
  • refusal of couples to give consent to join the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Mascarenhas MN, Flaxman SR, Boerma T, Vanderpoel S, Stevens GA. National, regional, and global trends in infertility prevalence since 1990: a systematic analysis of 277 health surveys. PLoS Med. 2012;9(12):e1001356. doi: 10.1371/journal.pmed.1001356. Epub 2012 Dec 18.

    PMID: 23271957BACKGROUND
  • Kocourkova J, Burcin B, Kucera T. Demographic relevancy of increased use of assisted reproduction in European countries. Reprod Health. 2014 May 26;11:37. doi: 10.1186/1742-4755-11-37.

    PMID: 24885428BACKGROUND

Central Study Contacts

Dr.Wageh Abd Elnasser

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2023

First Posted

May 30, 2023

Study Start

June 1, 2023

Primary Completion

September 1, 2023

Study Completion

January 1, 2024

Last Updated

May 31, 2023

Record last verified: 2023-05