Working IVF Patients' Quality of Life (WIQoL)

November 26, 2025 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU de Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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/
At baseline and through study completion, at 6 months or 12 months or 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Look for predictive factors of impaired quality of life.
Time Frame: At baseline and through study completion, at 6 months or 12 months or 18 months

Change in the Fertility Quality Of Life (FertiQoL) questionnaire score between baseline and follow-up visits. 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
Assess work/life interactions and their relationship to quality of life.
Time Frame: At baseline and through study completion, at 6 months or 12 months or 18 months
Work/life balance satisfaction questionnaire score. This questionnaire consists of 5 questions on the interaction between work and private life. For each question, the patient indicates on a scale from 1 (very unsatisfactory) to 5 (very satisfactory) his level of satisfaction.
At baseline and through study completion, at 6 months or 12 months or 18 months
Look for predictive factors of dropout.
Time Frame: At baseline and through study completion, at 6 months or 12 months or 18 months

Anxiety scale score (STAI trait at baseline only, STAI state for all visits). The STAI-Y (State Trait Anxiety Inventory) is a test designed to assess momentary and habitual anxiety.

The STAI-Y consists of 2 scales of 20 items each:

  • STAY form Y-A (state anxiety): 20 items for how the subject feels in the moment.
  • STAY form Y-B (trait anxiety): 20 propositions to find out what the subject usually feels.

Each item has a score ranging from 1 to 4 (4 being the highest degree of anxiety). The AE score= sum of the 20 questions on the State page. Ranges from 20 to 80. The AT score= sum of the 20 questions on the Trait page. Varies from 20 to 80.

Very high: > to 65 High: from 56 to 65 Medium: 46 to 55 Low: 36 to 45 Very low: < or =35
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...)
Time Frame: At baseline and through study completion, at 6 months or 12 months or 18 months

Beck Depression Inventory (BDI) score. The short validated version is composed of 13 items. This is the most widely used depression questionnaire in the adult population. It provides a quantitative estimate of the intensity of depression. Each item consists of 4 sentences corresponding to 4 degrees of increasing intensity on a scale of 0 to 3.

The global score of the depressive syndrome (from 0 to 39) is obtained by adding the scores of the 13 items.

  • A score of 0 to 4 corresponds to no depression,
  • From 4 to 7: mild depression,
  • From 8 to 15: moderate depression,
  • A score > 16: severe depression
At baseline and through study completion, at 6 months or 12 months or 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2021

Primary Completion (Actual)

March 8, 2024

Study Completion (Actual)

November 7, 2025

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0426

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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