Infertility, FemaleEMOT-IVFNCT04419740
Impact of a Mindfulness Intervention on Infertile Women Undergoing Assisted Reproductive Technique Treatments
A study testing Mindfulness based psychological intervention in people with Infertility, Female, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Infertility and its treatments can have a significant impact on women's psychological health. Anxiety has a negative impact on quality of life during treatment and can lead to withdrawal of care. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Mindfulness based psychological intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants fulfilling all of the following inclusion criteria are eligible for the study:
- French-speaking
- Women between the ages of 18-42 years
- Scheduled for the first IVF treatment in HUG/CHUV/CPMA Lausanne
- Access to a computer/smartphone/tablet with access to internet and a valid Email address
- Informed Consent as documented by her signature on the form (Appendix Informed Consent Form)
Who cannot join
- Psychotropic medication
- Ongoing psychiatric/psychological treatment
- Known severe psychiatric co-morbidity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sonia Campelo, RN contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospitals of Geneva
Geneva, 1206
Noemie Guedj, MD, 0795538546, noemie.guedj@hug.ch
sonia Campelo, RN, sonia.campelo@hug.ch
About this study
Official title: What is the Impact of an E-tool Based Mindfulness Intervention on Psychological Outcomes Compared to no Intervention in Infertile Women Undergoing Assisted Reproductive Technique Treatments: A Randomized Controlled Study?
Infertility and its treatments can have a significant impact on women's psychological health. Anxiety has a negative impact on quality of life during treatment and can lead to withdrawal of care. the investigators would like to test the effectiveness of an application available via the Internet that offers daily exercises such as mindfulness meditation. Women in the "treatment" group will be instructed to practice meditation exercises using the 15-minute daily application during in vitro fertilization treatment until pregnancy testing. Women in the control group will have the standard care of the centre. The investigators will measure the effectiveness of the intervention on anxiety, depression, quality of life and mindfulness aspects. The investigators will also assess the impact on the chances of pregnancy and stress.
Read the detailed description
Infertility is an unexpected and stressful life with emotional, social and sexual repercussions. Women undergoing assisted reproductive techniques (ART) exhibit high anxiety and/or depression scores during the pre-treatment period, during the course of treatment and during the 2 weeks waiting-time for the pregnancy test.
The impact of psychological distress on ART outcomes is debated. Several studies report a negative impact of stress on pregnancy rates after IVF whereas two meta-analyses report inconclusive results regarding the association between emotional distress and pregnancy outcomes after ART.
The success rates of ART, which are highly dependent on the woman's age, are low in women in their late reproductive years with the need of several ART treatments to achieve pregnancy. Moreover, ART is often the last resort treatment in couples that have undergone infertility investigations and other first-line treatments such as surgery, ovulation induction and/or stimulation with intra-uterine insemination. Couple need resilience in order to undergo repeated treatments. Psychological distress therefore has an impact on cumulative pregnancy rates over several ART treatments because of premature treatment discontinuation. Depressive symptoms at baseline have been shown to predict treatment "dropout" after only one cycle.
Preliminary evidence suggests that mind-body interventions, including mindfulness-based interventions and yoga, may be effective in reducing mental health difficulties such as anxiety and depression in infertile women undergoing treatments.
The aim of the investigators was to develop a psychological self-help tool using modern technological means in line with the recent Femtech (female technology) developments. The hypothesis was that an online meditation tool would be more accessible and easier to integrate into a busy schedule than standard programs that require weekly attendance.
In 2017, the investigators created collaboration between experts in reproductive medicine, experts in mindfulness and a start-up that offers an online platform for meditation programs. The investigators developed an online program of 15 meditations specifically dedicated to infertile women. These meditations help women explore certain themes such as "inner resources", "social interactions", "letting go of beliefs" etc. This program has been available online since December 2017 and has been used by several thousand women.
The hypothesis behind the study is that "mindfulness-based interventions" can be delivered successfully through modern technologies with a significant impact on psychological outcomes and well-being. Femtech self-help online tools are used by thousands of women on a daily basis but studies are lacking on their efficacy.
The aim is to conduct a randomized controlled trial on the effect of a mindfulness-based intervention using the online meditation program versus standard care without intervention on psychological outcomes in infertile women undergoing ART treatments.
Women in the intervention group will receive an introduction to the concept and philosophy of mindfulness meditation through an online video and an exercise book. They will receive an access code to the application and will have access to short guided meditations both general and specific to their infertility. They will be instructed to follow the "découverte" (discovery) program of 8 meditations of 10 minutes and then the program "désir de parentalité" (wish to become a parent) of 15 meditations of 13 minutes each. Patients will be given access to all other meditations programs on the application and instructed to meditate with the program for at least 10-15 minutes on a daily basis using the e-tool for 1 month. The practice of meditation will be monitored by the number of connections to the applications and the time spent on the exercises. Women in the control group will have the standard care of the centre. The investigators will measure the effectiveness of the intervention on anxiety (State trait anxiety index, STAI), depression (Beck depression inventory, BDI), quality of life during ART treatments (Fertility quality of life tool, Fertiqol) and mindfulness aspects (Five facet mindfulness questionnaire, FFMQ). The investigators will also measure the impact of the intervention on biological stress measured by hair cortisol concentration. Finally, the investigators will assess the impact on the chances of pregnancy and on treatment discontinuation after 1 month.
- Conditions
- Infertility, Female
- Being tested
- Mindfulness based psychological intervention
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based psychological interventionBehavioural
Women in the intervention group will have to use an application during 1 month. They will do meditation during 15 minutes each day.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness based psychological intervention | Experimental | Patients allocated to the intervention group will receive an email with a link to a video and a pdf document. The video and the pdf document will introduce them to the principles and the practice of mindfulness. They will also receive an access code to an e-tool valid for 1 month. On this e-tool the patient will have access to short guided meditations both general and specific to infertility. They will be instructed to follow the "découverte" (discovery) program of 8 meditations of 10 minutes and then the program "désir de parentalité (wish to become a parent) of 13 minutes 15 meditations of 13 minutes each. Patients will be given access to all other meditations programs of PetitBambou and instructed to meditate with the program for at least 10-15 minutes on a daily basis. Receives: Behavioral: Mindfulness based psychological intervention |
| Standard care | No intervention | The control group will have no additional intervention and will receive standard care in the institution. Women in all 3 study sites have access to counselling/psychological support with a trained professional before treatment initiation. During that consultation coping and stress reduction strategies are discussed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety state scores
The primary aim of the study is to evaluate the effect of an e-tool based intervention versus standard care without intervention on anxiety state measured by the French version of state trait anxiety index in infertile women undergoing ART.
State trait anxiety index state scores will be evaluated by completion of a questionnaire at 3 time points: baseline, at the time of the oocyte retrieval, on the day before the pregnancy test (before the results).
A score between 31 and 36 is considered as normal score.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Oct 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Streuli, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419740
- Sponsor's protocol ID
- EMOT-IVF
- Acronym
- EMOT-IVF
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Impact of an E-tool Based Mindfulness Intervention on Psychological Outcomes Compared to no Intervention in Infertile Women Undergoing Assisted Reproductive Technique Treatments: A Randomized Controlled Study?
- ClinicalTrials.gov ID
- NCT04419740
- Acronym / sponsor ID
- EMOT-IVF / EMOT-IVF
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jun 2020 (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 and its treatments can have a significant impact on women's psychological health. Anxiety has a negative impact on quality of life during treatment and can lead to withdrawal of care. the investigators would like to test the effectiveness of an application available via the Internet that offers daily exercises such as mindfulness meditation. Women in the "treatment" group will be instructed to practice meditation exercises using the 15-minute daily application during in vitro fertilization treatment until pregnancy testing. Women in the control group will have the standard care of the centre. The investigators will measure the effectiveness of the intervention on anxiety, depression, quality of life and mindfulness aspects. The investigators will also assess the impact on the chances of pregnancy and stress.
Detailed description
Infertility is an unexpected and stressful life with emotional, social and sexual repercussions. Women undergoing assisted reproductive techniques (ART) exhibit high anxiety and/or depression scores during the pre-treatment period, during the course of treatment and during the 2 weeks waiting-time for the pregnancy test.
The impact of psychological distress on ART outcomes is debated. Several studies report a negative impact of stress on pregnancy rates after IVF whereas two meta-analyses report inconclusive results regarding the association between emotional distress and pregnancy outcomes after ART.
The success rates of ART, which are highly dependent on the woman's age, are low in women in their late reproductive years with the need of several ART treatments to achieve pregnancy. Moreover, ART is often the last resort treatment in couples that have undergone infertility investigations and other first-line treatments such as surgery, ovulation induction and/or stimulation with intra-uterine insemination. Couple need resilience in order to undergo repeated treatments. Psychological distress therefore has an impact on cumulative pregnancy rates over several ART treatments because of premature treatment discontinuation. Depressive symptoms at baseline have been shown to predict treatment "dropout" after only one cycle.
Preliminary evidence suggests that mind-body interventions, including mindfulness-based interventions and yoga, may be effective in reducing mental health difficulties such as anxiety and depression in infertile women undergoing treatments.
The aim of the investigators was to develop a psychological self-help tool using modern technological means in line with the recent Femtech (female technology) developments. The hypothesis was that an online meditation tool would be more accessible and easier to integrate into a busy schedule than standard programs that require weekly attendance.
In 2017, the investigators created collaboration between experts in reproductive medicine, experts in mindfulness and a start-up that offers an online platform for meditation programs. The investigators developed an online program of 15 meditations specifically dedicated to infertile women. These meditations help women explore certain themes such as "inner resources", "social interactions", "letting go of beliefs" etc. This program has been available online since December 2017 and has been used by several thousand women.
The hypothesis behind the study is that "mindfulness-based interventions" can be delivered successfully through modern technologies with a significant impact on psychological outcomes and well-being. Femtech self-help online tools are used by thousands of women on a daily basis but studies are lacking on their efficacy.
The aim is to conduct a randomized controlled trial on the effect of a mindfulness-based intervention using the online meditation program versus standard care without intervention on psychological outcomes in infertile women undergoing ART treatments.
Women in the intervention group will receive an introduction to the concept and philosophy of mindfulness meditation through an online video and an exercise book. They will receive an access code to the application and will have access to short guided meditations both general and specific to their infertility. They will be instructed to follow the "découverte" (discovery) program of 8 meditations of 10 minutes and then the program "désir de parentalité" (wish to become a parent) of 15 meditations of 13 minutes each. Patients will be given access to all other meditations programs on the application and instructed to meditate with the program for at least 10-15 minutes on a daily basis using the e-tool for 1 month. The practice of meditation will be monitored by the number of connections to the applications and the time spent on the exercises. Women in the control group will have the standard care of the centre. The investigators will measure the effectiveness of the intervention on anxiety (State trait anxiety index, STAI), depression (Beck depression inventory, BDI), quality of life during ART treatments (Fertility quality of life tool, Fertiqol) and mindfulness aspects (Five facet mindfulness questionnaire, FFMQ). The investigators will also measure the impact of the intervention on biological stress measured by hair cortisol concentration. Finally, the investigators will assess the impact on the chances of pregnancy and on treatment discontinuation after 1 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness based psychological intervention | Experimental | Behavioral: Mindfulness based psychological interventionPatients allocated to the intervention group will receive an email with a link to a video and a pdf document. The video and the pdf document will introduce them to the principles and the practice of mindfulness. They will also receive an access code to an e-tool valid for 1 month. On this e-tool the patient will have access to short guided meditations both general and specific to infertility. They will be instructed to follow the "découverte" (discovery) program of 8 meditations of 10 minutes and then the program "désir de parentalité (wish to become a parent) of 13 minutes 15 meditations of 13 minutes each. Patients will be given access to all other meditations programs of PetitBambou and instructed to meditate with the program for at least 10-15 minutes on a daily basis. |
| Standard care | No intervention | –The control group will have no additional intervention and will receive standard care in the institution. Women in all 3 study sites have access to counselling/psychological support with a trained professional before treatment initiation. During that consultation coping and stress reduction strategies are discussed. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants fulfilling all of the following inclusion criteria are eligible for the study:
- French-speaking
- Women between the ages of 18-42 years
- Scheduled for the first IVF treatment in HUG/CHUV/CPMA Lausanne
- Access to a computer/smartphone/tablet with access to internet and a valid Email address
Key exclusion criteria (3 listed)
- Psychotropic medication
- Ongoing psychiatric/psychological treatment
- Known severe psychiatric co-morbidity
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 |
|---|---|---|
| Mindfulness based psychological interventionWomen in the intervention group will have to use an application during 1 month. They will do meditation during 15 minutes each day. | Behavioural | Mindfulness based psychological intervention |
Primary outcome
Change in anxiety state scores
Time frame: 1 month
The primary aim of the study is to evaluate the effect of an e-tool based intervention versus standard care without intervention on anxiety state measured by the French version of state trait anxiety index in infertile women undergoing ART. State trait anxiety index state scores will be evaluated by completion of a questionnaire at 3 time points: baseline, at the time of the oocyte retrieval, on the day before the pregnancy test (before the results). A score between 31 and 36 is considered as normal score.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Sonia Campelo, RN contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based psychological intervention in people with Infertility, Female, run by University Hospital, Geneva at 1 site in Switzerland.
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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Mar 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noemie SACHS GUEDJ, MD (+41795538546, noemie.guedj@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety state scores (time frame: 1 month). 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 27 Mar 2026.