Skip to main content
Clinical Trials/NCT04966091
NCT04966091
Completed
Not Applicable

Working IVF Patients' Quality of Life

University Hospital, Montpellier1 site in 1 country200 target enrollmentSeptember 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
In Vitro Fertilization (IVF)
Sponsor
University Hospital, Montpellier
Enrollment
200
Locations
1
Primary Endpoint
Evaluate the evolution of the quality of life of active patients during their IVF course.
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

Infertility affects approximately 1 in 6 couples and may require the use of Medically Assisted Reproduction techniques. In France, there were more than 60,000 in vitro fertilization (IVF) attempts in 2016. The burden of the IVF process is even more significant for working women, causing significant absenteeism due to medical appointments but also to the psychological discomfort caused by the management. Unfortunately, there are no studies that specifically address the quality of life of working women undergoing IVF.

The cohort project aims to measure quality of life using validated questionnaires (FertiQoL, STAI Anxiety Scale and BDI Depression Inventory) in active patients who are scheduled for a first IVF attempt. Quality of life will be measured before starting treatment and at embryo transfer and will be followed up at each embryo transfer for a maximum period of 18 months. The follow-up will end after the live birth of a child or at the end of the 18 months of follow-up.

The investigators will also evaluate, by means of a specific questionnaire, the satisfaction with the interactions between professional and private life (management and consequences of absenteeism at work, consequences on professional evolution, anxious repercussions in the professional and private domains) in the active women undergoing IVF treatment.

Registry
clinicaltrials.gov
Start Date
September 13, 2021
End Date
November 7, 2025
Last Updated
5 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Professionally active women aged 18 to 42 years
  • Beginning in vitro fertilization treatment at the Montpellier University Hospital

Exclusion Criteria

  • Women who have already had an IVF attempt in the process of egg donation or pre-implantation diagnosis
  • History of psychotic or dissociative disorder
  • Not fluent in French
  • Not affiliated to a social security system
  • Protected by law or under curators/guardianship
  • No record of non-objection to participate in the study

Outcomes

Primary Outcomes

Evaluate the evolution of the quality of life of active patients during their IVF course.

Time Frame: At baseline and through study completion, at 6 months or 12 months or 18 months

Assessed by the Fertility Quality Of Life (FertiQoL) questionnaire score at 18 months or end of follow-up, compared with the one obtained at inclusion. The score obtained from this questionnaire is not based on a scale. 2 first items measures physical health and satisfaction with the quality of life in terms of fertility. 24 other items assesses the impact of fertility problems in several domains: 6 in the emotional, 6 in mind-body, 6 in the relational, 6 in social. http://sites.cardiff.ac.uk/fertiqol/description/instrument-description/

Secondary Outcomes

  • Look for predictive factors of dropout.(At baseline and through study completion, at 6 months or 12 months or 18 months)
  • Assess work/life interactions and their relationship to quality of life.(At baseline and through study completion, at 6 months or 12 months or 18 months)
  • Look for predictive factors of impaired quality of life.(At baseline and through study completion, at 6 months or 12 months or 18 months)
  • To compare the characteristics of patients who achieve pregnancy versus those who fail (Quality of life, anxiety, depression...)(At baseline and through study completion, at 6 months or 12 months or 18 months)

Study Sites (1)

Loading locations...

Similar Trials