Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04829877

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Infertility Biofeedback Genital Diseases Heart Rate Variability Urogenital Diseases

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Infertility clinic

Taipei, 110, Taiwan

Location status: Recruiting

Location contact

Jin-Ru Chang, BS

CONTACT

About this study

A designed data entry system for the current study will be developed to ensure an error-proof process. It is important to inspect data for outliers, wild code, and consistency to maintain the data quality in the pre-analysis data phase. We will assess the amount and pattern of missing values by using descriptive statistics, such as frequency and percentage. The pattern of missing data will be identified and decide whether the missing completely at random or not. The appropriate corresponding method will be adopted for the subsequent statistical analyses. For example, the mean imputation is considered when the percentage of items missing at a given questionnaire is less than 10 %. The mean imputation will be used to replaces a missing value with the item mean when applicable. The comparison between complete case analysis and imputation data will be performed to assess the reliability and validity of the results.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based mind-body intervention with HRVB

Behavioral

The web-based mind-body intervention with HRVB contains the following components: 1) Breathing training with HRV biofeedback; 2) 5 different topics will be included ; 3) Home exercise of slow breathing and mindfulness exercise.

Web-based mind-body intervention

Behavioral

The web-based mind-body intervention will receive 5 different topics courses.

Primary outcomes

  1. Anxiety

    Time frame: Baseline

    Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).

  2. Anxiety

    Time frame: 1 week post-intervention

    Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).

  3. Anxiety

    Time frame: 1 month post-intervention

    Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).

  4. Anxiety

    Time frame: 2 month post-intervention

    Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).

  5. Anxiety

    Time frame: 3 month post-intervention

    Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).

Secondary outcomes

  1. Depressive symptoms

    Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3

    The Taiwanese version of the Beck Depression Inventory (BDI) will be used to assess depressive symptoms among infertility women.

  2. HRV function

    Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3

    The HRV signal will be measured using standard equipment.

  3. Mindful awareness

    Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3

    The Taiwanese version of the Five Facet Mindfulness Questionnaire (FFMQ) will be adopted to assess levels of mindfulness.

  4. Infertility self-efficacy

    Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3

    The infertility Self-Efficacy Scale (ISE) will be used for studied women.

  5. Pregnancy rates

    Time frame: 15 days after embryo transfer or ultrasound

    Clinical pregnancy will be defined as a positive blood, urinary pregnancy test.

Study contacts

Contact information is provided by the study sponsor or research team.

Shu-Yu Kuo, Phd

CONTACT

[email protected]

+886-2-2736-1661 ext. 6301

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Trajectory of Psychological Distress Among Infertility Women: Efficacy and Mechanism of Mind-body Intervention With Heart Rate Variability Biofeedback

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2021
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.