In Vitro Fertilization (IVF)WIQoLNCT04966091
Working IVF Patients' Quality of Life
An observational study of In Vitro Fertilization (IVF) and Infertility, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- In Vitro Fertilization (IVF), Infertility
- What is being tested?
- Completion of questionnaires
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2021to 7 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Active women, aged between 18 and 42, undergoing IVF at Montpellier University Hospital.
Who may be able to join
- Professionally active women aged 18 to 42 years
- Beginning in vitro fertilization treatment at the Montpellier University Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- In Vitro Fertilization (IVF), Infertility
- Being tested
- Completion of questionnaires
- Keywords
- Infertility, Assisted Reproductive Techniques, quality of life, work, personal and professional interactions, depression
- Medical subject headings
- Infertility, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of questionnairesOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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/
Measured: 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.
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/
Measured: 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.
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.
Measured: At baseline and through study completion, at 6 months or 12 months or 18 months
Look for predictive factors of dropout.
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
Measured: 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...)
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
Measured: At baseline and through study completion, at 6 months or 12 months or 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start13 Sep 2021
- Primary completion8 Mar 2024
- Study completion7 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro Fertilization (IVF)Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966091
- Sponsor's protocol ID
- RECHMPL20_0426
- Acronym
- WIQoL
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working IVF Patients' Quality of Life
- ClinicalTrials.gov ID
- NCT04966091
- Acronym / sponsor ID
- WIQoL / RECHMPL20_0426
- Conditions
- In Vitro Fertilization (IVF), Infertility
- Keywords
- Infertility, Assisted Reproductive Techniques, quality of life, work, personal and professional interactions, depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Active women, aged between 18 and 42, undergoing IVF at Montpellier University Hospital.
Key inclusion criteria (2 listed)
- Professionally active women aged 18 to 42 years
- Beginning in vitro fertilization treatment at the Montpellier University Hospital
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Completion of questionnairesThe 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). | Other | – |
Primary outcome
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/
4 secondary outcomes
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
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
Look for predictive factors of dropout.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In Vitro Fertilization (IVF) and Infertility, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.