Mindfulness intervention for women facing infertility treatments
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?
This study is testing whether a mindfulness app can help women dealing with infertility treatments feel less anxious and improve their overall well-being during IVF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva) |
| Trial ID | NCT04419740 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a mindfulness application designed for women undergoing assisted reproductive techniques (ART) to help manage anxiety and improve psychological well-being. Participants in the treatment group will engage in daily 15-minute mindfulness meditation exercises during their IVF treatment, while the control group will receive standard care. The study aims to measure changes in anxiety, depression, quality of life, and mindfulness, as well as the potential impact on pregnancy rates and stress levels. By addressing psychological distress, the study seeks to enhance the overall experience and outcomes for women facing infertility.
Who should consider this trial
Good fit: Ideal candidates are French-speaking women aged 18-42 who are scheduled for their first IVF treatment at the University Hospitals of Geneva.
Not a fit: Patients currently on psychotropic medication or undergoing psychiatric treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and pregnancy outcomes for women undergoing infertility treatments.
How similar studies have performed: Preliminary evidence suggests that mindfulness-based interventions have shown promise in reducing mental health distress in similar populations, although results regarding pregnancy outcomes remain inconclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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) Exclusion Criteria: * Psychotropic medication * Ongoing psychiatric/psychological treatment * Known severe psychiatric co-morbidity
Where this trial is running
Geneva
- University Hospitals of Geneva — Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Noemie SACHS GUEDJ, MD
- Email: noemie.guedj@hug.ch
- Phone: +41795538546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.