Trajectory of Psychological Distress Among Infertility Women

Background: Infertility is a serious reproductive health issue and affects 48.5 million couples worldwide. Women undergoing fertility treatment often experienced psychological distress but also social stigma that is close linked to later pregnancy outcome. Despite the advancement in assisted reproductive technology, effective interventions for reducing stress, anxiety, and depressive symptoms for infertility women remain lacking. Objectives: The objective of this proposal is to evaluate the efficacy of web-based mind-body intervention combining HRV biofeedback on the infertility women's anxiety symptoms, levels of depression, HRV function, mindful awareness, infertility self-efficacy, and pregnancy rates. Methods: We plan to conduct a randomized controlled trial on the web-based mind-body intervention combining heart rate variability biofeedback. Eligible women will be recruited and randomized into three groups. Intention-to-treat analysis and mixed regression modeling will be used to estimate the effectiveness of the interventions. Anticipatory results: Effective strategies will be determined for infertility women.

NCT Number	NCT04829877
Lead Sponsor	Taipei Medical University
Conditions	Infertility, Heart Rate Variability, Biofeedback
Enrollment	750 participants
Start Date	2022-04-19
Primary Completion	2025-04 (estimated)
Study Completion	2025-04 (estimated)
Updated on ClinicalTrials.gov	2025-01-27