Clinical trial NCT04966091: Working IVF Patients' Quality of Life
Official title: Working IVF Patients' Quality of Life
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: In Vitro Fertilization (IVF)
Infertility
Keywords: Infertility
Assisted Reproductive Techniques
quality of life
work
personal and professional interactions
depression
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active women, aged between 18 and 42, undergoing IVF at Montpellier University Hospital.

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.


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

Primary outcomes:
measure: Evaluate the evolution of the quality of life of active patients during their IVF course.
timeFrame: At baseline and through study completion, at 6 months or 12 months or 18 months
Secondary outcomes:
measure: Look for predictive factors of impaired quality of life.
timeFrame: At baseline and through study completion, at 6 months or 12 months or 18 months
measure: Assess work/life interactions and their relationship to quality of life.
timeFrame: At baseline and through study completion, at 6 months or 12 months or 18 months
measure: Look for predictive factors of dropout.
timeFrame: At baseline and through study completion, at 6 months or 12 months or 18 months
measure: To compare the characteristics of patients who achieve pregnancy versus those who fail (Quality of life, anxiety, depression...)
timeFrame: At baseline and through study completion, at 6 months or 12 months or 18 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
Study officials:
References: