Trajectory of Psychological Distress Among Infertility Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-60
SponsorTaipei Medical University

About this trial

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

Qualifiers

20-year-old and above

Seeking infertility care

Contemplating pregnancy

Intended to start their ART cycle

Disqualifiers

Diagnosis of cardiovascular disease, depressive disorder, anxiety disorder, cardiac arrhythmia

Already had started their ART treatment

Taking medications that might affect ANS activity

Trial design

Treatments tested in this trial

  • Web-based mind-body intervention with HRVB
  • Web-based mind-body intervention

Treatment groups

750 Participants
are divided into 3 treatment groups

Sponsors and collaborators