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Trajectory of Psychological Distress Among Infertility Women

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 27, 2025 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Jan 2024 to Apr 2025v6
  2. Primary and study completion dates: Dec 2022 to Jan 2024v5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2022 to Apr 19, 2022
    v4
  4. Primary completion date: Jan 2022 to Dec 2022v3 Show 4 more changesShow less
    • Start date: Sep 2021 to Apr 2022
    • Primary endpoints: 3 to 5
    • Study completion date: Mar 2022 to Dec 2022
    • Secondary endpoints: details revised at 4 of 5 entries
  5. Start date: May 2021 to Sep 2021
    • Primary completion date: Dec 2021 to Jan 2022
    • Study completion date: May 2022 to Mar 2022
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04829877
Lead Sponsor Taipei Medical University
Conditions
(from sponsor)		 Infertility, Heart Rate Variability, Biofeedback
Related terms Infertility
Enrollment 750 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov