NCT04829877 Trajectory of Psychological Distress Among Infertility Women
| NCT ID | NCT04829877 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taipei Medical University |
| Condition | Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2022-04-19 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 750 participants in total. It began in 2022-04-19 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 20-year-old and above * Seeking infertility care * Contemplating pregnancy * Intended to start their ART cycle * Able to speak Taiwanese or Mandarin Exclusion Criteria: * Diagnosis of cardiovascular disease, depressive disorder, anxiety disorder, cardiac arrhythmia * Already had started their ART treatment * Taking medications that might affect ANS activity
Contact & Investigator
Shu-Yu Kuo, Phd
PRINCIPAL INVESTIGATOR
Taipei Medical University
Frequently Asked Questions
Who can join the NCT04829877 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 60 Years, studying Infertility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04829877 currently recruiting?
Yes, NCT04829877 is actively recruiting participants. Contact the research team at sykuo@tmu.edu.tw for enrollment information.
Where is the NCT04829877 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT04829877 clinical trial?
NCT04829877 is sponsored by Taipei Medical University. The principal investigator is Shu-Yu Kuo, Phd at Taipei Medical University. The trial plans to enroll 750 participants.