NCT05078996

Brief Summary

This study was conducted in a cross-sectional descriptive type with 160 infertile women who were treated in the IVF Clinic of a university hospital between July - October 2020 in order to evaluate the effect of patient-centered care approach in infertility on treatment-related quality of life. The data of the study were collected face to face through the "Introductory Information Form" "Patient Centered Care Form for Infertile Women" and "FertiQol Treatment Module".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 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

Study Start

First participant enrolled

June 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

June 19, 2021

Last Update Submit

September 21, 2023

Conditions

Patient Centred CareCompliance, TreatmentInfertility, FemaleQuality of Life

Keywords

patient centred careFertiQolinfertilityquality of lifenursing

Outcome Measures

Primary Outcomes (1)

  • Treatment-related quality of life

    FertiQol Treatment Module was used to evaluate treatment-related quality of life. This module is a sub-module within FertiQol Scale which developed by Boivin et al. (2011). Module has 10 questions about treatments physical and emotional effects. Module has two subdimensions called "Environment" and "Tolerability" and each subdimensions and total scale score can between 0-100 points.

    from obtaining ethical permission to reaching sampling (approximately 6 months)

Secondary Outcomes (1)

  • Patient Centred Care

    from obtaining ethical permission to reaching sampling (approximately 6 months)

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who diagnosed with infertility

You may qualify if:

  • Diagnosed with infertility
  • Has no commnunication problems

You may not qualify if:

  • Communication problems (e.g language)
  • Diagnosed by diseases with reproductive problems but not infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elif Balkan

Istanbul, 34510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient ComplianceInfertility, FemaleInfertility

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master of Science

Study Record Dates

First Submitted

June 19, 2021

First Posted

October 15, 2021

Study Start

June 1, 2020

Primary Completion

September 20, 2020

Study Completion

November 30, 2020

Last Updated

September 25, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)