NCT05681130

Brief Summary

Psychological status of couples attending to IVF programmes is important due to possible effect on final result. Observers aim to investigate the depression, anxiety and stress scores of couples before and after the procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

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

Study Start

First participant enrolled

March 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

December 27, 2022

Last Update Submit

February 17, 2024

Conditions

StressPregnancy

Keywords

depressionanxietystresspregnancyIVF

Outcome Measures

Primary Outcomes (1)

  • positive pregnancy test

    blood test will be taken after embryo (blastocyst) transfer

    12 days after embryo transfer

Study Arms (2)

1 women attending IVF programme

Women attending to IVF programme will be evaluated for pscyhological parameters before and after the precedure

Other: questionaire

2 partners of women attending to IVF programme

Men who are partners of women attending to IVF programme will be evaluated for pscyhological parameters before and after the precedure

Other: questionaire

Interventions

questionaireOTHER

two questionaires for each group

1 women attending IVF programme2 partners of women attending to IVF programme

Eligibility Criteria

Age20 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsreproductive aged women
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women ages 20-40, without history of RIF or known genetic aneuploidy. Men without severe sperm problem without known genetic aneuploidiy. Only blastocyst transferred copules will be eligible for final analysis.

You may qualify if:

  • to 40 year old women attending to IVF programme

You may not qualify if:

  • Azospermia and severe male factor for whom sperm freezing will be required
  • History of RIF
  • Known genetik abnormality of couples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurofertil

Bursa, 16000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • gerçek aydın

    Eurofertil IVF Health Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 12, 2023

Study Start

March 1, 2022

Primary Completion

February 17, 2024

Study Completion

February 17, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

TU(1)