NCT04966091

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 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

First Submitted

Initial submission to the registry

July 7, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 13, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2024

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2025

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

July 7, 2021

Last Update Submit

November 26, 2025

Conditions

Keywords

InfertilityAssisted Reproductive Techniquesquality of lifeworkpersonal and professional interactionsdepression

Outcome Measures

Primary Outcomes (1)

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

    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/

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

Secondary Outcomes (4)

  • Look for predictive factors of impaired quality of life.

    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 dropout.

    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

Interventions

The quality of life questionnaire will be completed before starting the treatment and then during the embryo transfer and will be followed up at each embryo transfer over a maximum period of 18 months. We will also evaluate by means of a specific questionnaire the importance of work/life interactions management and consequences of absenteeism at work, consequences on professional evolution, anxious repercussions in the professional and private domains).

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Active women, aged between 18 and 42, undergoing IVF at Montpellier University Hospital.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

InfertilityDepression

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2021

First Posted

July 19, 2021

Study Start

September 13, 2021

Primary Completion

March 8, 2024

Study Completion

November 7, 2025

Last Updated

November 28, 2025

Record last verified: 2025-11

Locations