InfertilityNCT04829877
Trajectory of Psychological Distress Among Infertility Women
A study testing Web-based mind-body intervention with HRVB and Web-based mind-body intervention in people with Infertility and Heart Rate Variability, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Heart Rate Variability, Biofeedback
- What is being tested?
- Web-based mind-body intervention with HRVB and Web-based mind-body intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Apr 2022to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-year-old and above
- Seeking infertility care
- Contemplating pregnancy
- Intended to start their ART cycle
- Able to speak Taiwanese or Mandarin
Who cannot join
- Diagnosis of cardiovascular disease, depressive disorder, anxiety disorder, cardiac arrhythmia
- Already had started their ART treatment
- Taking medications that might affect ANS activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Infertility clinic
Taipei, 110
Jin-Ru Chang, BS
About this study
Official title: Trajectory of Psychological Distress Among Infertility Women: Efficacy and Mechanism of Mind-body Intervention With Heart Rate Variability Biofeedback
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Infertility, Heart Rate Variability, Biofeedback
- Being tested
- Web-based mind-body intervention with HRVB, Web-based mind-body intervention
- Keywords
- infertility, mind-body intervention, heart rate variability, biofeedback, psychological distress
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based mind-body intervention with HRVBBehavioural
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 interventionBehavioural
The web-based mind-body intervention will receive 5 different topics courses.
| Study group | Role | What they receive |
|---|---|---|
| Web-based mind-body intervention with HRVB | Experimental | Both standard usual care and the web-based mind-body intervention with HRV biofeedback (MBI-HRVB) will be provided to the participants. The web-based mind-body intervention with HRV biofeedback program consisted of 5-week training sessions and breathing training. Receives: Behavioral: Web-based mind-body intervention with HRVB |
| Web-based mind-body intervention | Experimental | Both standard usual care and the web-based mind-body intervention will be provided to the participants. The web-based mind-body intervention program consisted of 5-week training sessions. Receives: Behavioral: Web-based mind-body intervention |
| Control | No intervention | The women in the control group will receive the standard usual care provided at the fertility clinic. The standard care protocols encompass elements such as routine assessment and health education at each visit. Participants enrolled in the control group will be approached once a week by a nurse to provide health consultation about fertility treatment, medication, signs, and symptoms of discomfort for five weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Measured: Baseline
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Measured: 1 week post-intervention
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Measured: 1 month post-intervention
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Measured: 2 month post-intervention
Anxiety
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Measured: 3 month post-intervention
Secondary outcomes (5)
Depressive symptoms
The Taiwanese version of the Beck Depression Inventory (BDI) will be used to assess depressive symptoms among infertility women.
Measured: Baseline, post-intervention 1 week, month 1 , 2 and 3
HRV function
The HRV signal will be measured using standard equipment.
Measured: Baseline, post-intervention 1 week, month 1 , 2 and 3
Mindful awareness
The Taiwanese version of the Five Facet Mindfulness Questionnaire (FFMQ) will be adopted to assess levels of mindfulness.
Measured: Baseline, post-intervention 1 week, month 1 , 2 and 3
Infertility self-efficacy
The infertility Self-Efficacy Scale (ISE) will be used for studied women.
Measured: Baseline, post-intervention 1 week, month 1 , 2 and 3
Pregnancy rates
Clinical pregnancy will be defined as a positive blood, urinary pregnancy test.
Measured: 15 days after embryo transfer or ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start19 Apr 2022
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu Yu Kuo, Taipei Medical University
- Investigators
- Shu-Yu Kuo, Phd, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829877
- Sponsor's protocol ID
- N201807030
- Status last verified
- Jan 2025
- First submitted
- 31 Mar 2021
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectory of Psychological Distress Among Infertility Women: Efficacy and Mechanism of Mind-body Intervention With Heart Rate Variability Biofeedback
- ClinicalTrials.gov ID
- NCT04829877
- Acronym / sponsor ID
- N201807030
- Conditions
- Infertility, Heart Rate Variability, Biofeedback
- Keywords
- infertility, mind-body intervention, heart rate variability, biofeedback, psychological distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Web-based mind-body intervention with HRVB | Experimental | Behavioral: Web-based mind-body intervention with HRVBBoth standard usual care and the web-based mind-body intervention with HRV biofeedback (MBI-HRVB) will be provided to the participants. The web-based mind-body intervention with HRV biofeedback program consisted of 5-week training sessions and breathing training. |
| Web-based mind-body intervention | Experimental | Behavioral: Web-based mind-body interventionBoth standard usual care and the web-based mind-body intervention will be provided to the participants. The web-based mind-body intervention program consisted of 5-week training sessions. |
| Control | No intervention | –The women in the control group will receive the standard usual care provided at the fertility clinic. The standard care protocols encompass elements such as routine assessment and health education at each visit. Participants enrolled in the control group will be approached once a week by a nurse to provide health consultation about fertility treatment, medication, signs, and symptoms of discomfort for five weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 20-year-old and above
- Seeking infertility care
- Contemplating pregnancy
- Intended to start their ART cycle
- Able to speak Taiwanese or Mandarin
Key exclusion criteria (3 listed)
- Diagnosis of cardiovascular disease, depressive disorder, anxiety disorder, cardiac arrhythmia
- Already had started their ART treatment
- Taking medications that might affect ANS activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based mind-body intervention with HRVBThe 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. | Behavioural | Web-based mind-body intervention with HRVB |
| Web-based mind-body interventionThe web-based mind-body intervention will receive 5 different topics courses. | Behavioural | Web-based mind-body intervention |
Primary outcome
Anxiety
Time frame: Baseline
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Anxiety
Time frame: 1 week post-intervention
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Anxiety
Time frame: 1 month post-intervention
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Anxiety
Time frame: 2 month post-intervention
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
Anxiety
Time frame: 3 month post-intervention
Anxiety symptoms will be assessed using the Taiwanese version of the State Anxiety Inventory (SAI).
5 secondary outcomes
Depressive symptoms
Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3
HRV function
Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3
Mindful awareness
Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3
Infertility self-efficacy
Time frame: Baseline, post-intervention 1 week, month 1 , 2 and 3
Pregnancy rates
Time frame: 15 days after embryo transfer or ultrasound
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shu-Yu Kuo, Phd principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based mind-body intervention with HRVB and Web-based mind-body intervention in people with Infertility and Heart Rate Variability, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu-Yu Kuo, Phd (+886-2-2736-1661 ext. 6301, sykuo@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.