Impact of a Mindfulness Intervention on Infertile Women Undergoing Assisted Reproductive Technique Treatments

NCT04419740 | Recruiting

• 1 other identifier: EMOT-IVF
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Study Arms (2)

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.

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.

Interventions

Mindfulness based psychological intervention BEHAVIORAL

Women in the intervention group will have to use an application during 1 month. They will do meditation during 15 minutes each day.

Mindfulness based psychological intervention

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Psychotropic medication
• Ongoing psychiatric/psychological treatment
• Known severe psychiatric co-morbidity

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1206, Switzerland

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Central Study Contacts

Noemie SACHS GUEDJ, MD

CONTACT

+41795538546; noemie.guedj@hug.ch

Sonia Campelo, RN

CONTACT

sonia.campelo@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: June 5, 2020
• Study Start: October 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)