Actively Recruiting

Phase Not Applicable
Age: 20Years - 60Years
FEMALE
Healthy Volunteers
NCT04829877

Trajectory of Psychological Distress Among Infertility Women

Led by Taipei Medical University · Updated on 2025-01-27

750

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Trajectory of Psychological Distress Among Infertility Women

Who Can Participate

Age: 20Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 20 years old and above
  • Seeking infertility care
  • Contemplating pregnancy
  • Planning to start assisted reproductive technology (ART) cycle
  • Able to speak Taiwanese or Mandarin
Not Eligible

You will not qualify if you...

  • Diagnosis of cardiovascular disease, depressive disorder, anxiety disorder, or cardiac arrhythmia
  • Already started ART treatment
  • Taking medications that may affect autonomic nervous system activity

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Infertility clinic

Taipei, Taiwan, 110

Actively Recruiting

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Research Team

S

Shu-Yu Kuo, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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