InfertilityNCT05091450
Integrative Body-Mind-Spirit Group Intervention for Infertile Couples
A study testing Couple-based I-BMS intervention for infertility in people with Infertility, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a two-arm, with equal randomization, parallel randomized controlled trial. It compares the efficacy of a couple-based Integrative Body-Mind-Spirit (I-BMS) group intervention to a waitlist control group in improving dyadic couple flourishing and fertility-related quality of life among couples who are diagnosed… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Couple-based I-BMS intervention for infertility
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- are in a heterosexual marriage
- are clinically diagnosed of infertility
- are actively trying to conceive
- are able to understand, read and speak Chinese
- age 18 or above
- give consent to participate in this study
Who cannot join
- are being exposed to intimate partner violence within the past 12 months (HARK test score >=1)
- have signs of early psychosis within the past 12 months (Screen for Early Psychosis score = 2)
- have suicidal ideation in the past 2 weeks (Beck Depression Inventory II, item 9, score >= 2)
- already have a living child or children
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Social Work and Social Administration, The University of Hong Kong
Hong Kong
Celia Hoi-Yan Chan, PhD, (852) 3917 2089, chancelia@hku.hk
Victoria Ka-Ying Hui, PhD
About this study
Official title: Efficacy of a Couple-Based Integrative Body-mind-spirit Group Intervention for Infertile Couples on Improving Dyadic Couple Flourishing and Fertility Quality of Life: A Randomized Controlled Trial
This is a two-arm, with equal randomization, parallel randomized controlled trial. It compares the efficacy of a couple-based Integrative Body-Mind-Spirit (I-BMS) group intervention to a waitlist control group in improving dyadic couple flourishing and fertility-related quality of life among couples who are diagnosed of infertility in Hong Kong. It also aims to investigate the dyadic associations between infertile husbands' and wives' baseline primary outcomes and changes in primary outcomes following the intervention.
Read the detailed description
Infertility is a global public health issue, affecting approximately 15% of childbearing-aged couples around the world. It is often a challenging dyadic life experience that generates adverse impacts on the psychosocial well-being of couples at childbearing age. Numerous psychosocial interventions have been developed for infertile women, and their efficacy and effectiveness were supported empirically. This study attempts to address the limitations incurred in existing psychosocial interventions for infertility by: (1) including infertile men and couples who have not sought fertility treatment and (2) incorporating relational outcomes within psychosocial interventions for infertile couples. This is a two-arm, with equal randomization, parallel randomized controlled trial. It compares the efficacy of a couple-based Integrative Body-Mind-Spirit (I-BMS) group intervention to a waitlist control group in improving dyadic couple flourishing and fertility-related quality of life among couples who are diagnosed of infertility in Hong Kong. It also aims to investigate the dyadic associations between infertile husbands' and wives' baseline primary outcomes and changes in primary outcomes following the intervention.
On hundred and seventy-eight infertile couples will be recruited through hospitals, clinics and local communities in Hong Kong. Each prospective couple will complete an online screening survey. Eligible couples will complete the baseline assessment, and then be randomized in a ratio of 1:1 into one of the two arms. Arm 1 is the couple-based I-BMS intervention for infertility, which consists of four 3-hour sessions within one month. Arm 2 is the waitlist control. Randomization will be performed by a computer. All eligible couples will be contacted by a research assistant for a pre-group interview prior to the commencement of the I-BMS intervention. The primary outcomes are changes over the measurement points in dyadic couple flourishing and fertility quality of life. The secondary outcomes include changes over the measurement points in empathy towards partner, partnership, relationship satisfaction, anxiety, depression, infertility-related blame, and resilience. Assessments are administered at baseline, post-intervention, 1-month follow-up, and 5-year follow-up. Structural equation modelling will be employed to examine the efficacy of the couple-based I-BMS intervention based on the intention-to-treat principle, as well as the dyadic association between infertile husbands' and wives' primary outcomes.
Eight hypotheses are generated. First, it is hypothesized that, after controlling for baseline dyadic couple flourishing, couples in the I-BMS intervention group will report significantly higher dyadic couple flourishing than their counterparts in the waitlist control group following the intervention. Second, it is hypothesized that, after controlling for post-intervention dyadic couple flourishing, couples in the I-BMS intervention group will report significantly higher dyadic couple flourishing than their counterparts in the waitlist control group at one-month follow-up. Third, it is hypothesized that, after controlling for baseline dyadic fertility quality of life, couples in the I-BMS intervention group will report significantly higher dyadic fertility quality of life than their counterparts in the waitlist control group following the intervention. Fourth, it is hypothesized that, after controlling for post-intervention dyadic fertility quality of life, couples in the I-BMS intervention group will report significantly higher dyadic fertility quality of life than their counterparts in the waitlist control group at one-month follow-up. Fifth, it is hypothesized that wives' baseline fertility quality of life is predicted by their own and their husbands' baseline couple flourishing. Sixth, it is hypothesized that husbands' baseline fertility quality of life is predicted by their own and their wives' baseline couple flourishing. Seventh, it is hypothesized that wives' post-intervention improvements in fertility quality of life is predicted by their own and their husbands' post-intervention improvements in couple flourishing. Eighth, it is hypothesized that husbands' post-intervention improvements in fertility quality of life is predicted by their own and their wives' post-intervention improvements in couple flourishing.
- Conditions
- Infertility
- Being tested
- Couple-based I-BMS intervention for infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple-based I-BMS intervention for infertilityBehavioural
It is based on the previous I-BMS intervention for women undergoing IVF treatment, and aims to improve fertility quality of life and couple flourishing by (1) increasing awareness of the interconnectedness between physical and psychosocial well-being, (2) practicing body-mind-spirit techniques, (3) facilitating personal growth and partner empathy and compassion, and (3) creating the shared meaning of life, family, children. As a strength-focused and meaning-oriented approach, it utilizes experiential and self-reflective exercises to help participants reconstruct the meaning behind their ordeal and rediscover the strengths that keep them going.
| Study group | Role | What they receive |
|---|---|---|
| Couple-based I-BMS intervention for infertility | Experimental | The I-BMS intervention will be conducted face-to-face and in group format. It comprises four 3-hour sessions within one month. Two registered social workers who are professionally trained on I-BMS intervention model will deliver the intervention. Receives: Behavioral: Couple-based I-BMS intervention for infertility |
| Waitlist control | Other | Couples allocated in the waitlist control group will begin the I-BMS intervention (same as the intervention group) after completing the 1-month follow-up assessment. Receives: Behavioral: Couple-based I-BMS intervention for infertility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes over the measurement points in the Couple Flourishing Measure
It has 16 items measuring participants' perceived encouragement towards expanding goals, recognition of partner's strengths, and engagement in meaningful activities with their partner. Scores range from 16 to 112, where a higher score represents a higher level of couple flourishing.
Measured: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Changes over the measurement points in the Fertility Quality of Life Questionnaire - Core FertiQoL subscale
It has 24 items measuring the consequences of fertility problems on quality of life over four life domains (emotional, mind/body, relational, and social). Subscale scores range from 0 to 100, where a higher score represent a higher level of fertility quality of life.
Measured: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Secondary outcomes (6)
Changes over the measurement points in the Interpersonal Reactivity Index
It has 13 items measuring participants' tendency to view things from their partner's perspective and to have sympathy and concerns for partner's misfortune. Scores range from 0 to 52, where a higher score represent greater perspective taking and empathic concern.
Measured: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Changes over the measurement points in the Relationship Flourishing Scale
It has 12 items measuring participants' perception that meaningful connections, shared goals, and supportive activities in their relationship have helped each other grow as individuals and as a couple. Scores range from 12 to 60, where a higher score represents a higher level of relationship flourishing.
Measured: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Changes over the measurement points in the Brief Version of the Dyadic Adjustment Scale
It has 4 items measuring participants' perceived satisfaction towards their marriage. Scores range from 0 to 20, where a higher score represents greater marital satisfaction.
Measured: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Changes over the measurement points in the Hospital Anxiety and Depression Scale
It has 14 items measuring participants' levels of anxiety and depression. Subscale scores range from 0 to 21, where a higher score represents a higher level of anxiety or depression.
Measured: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Changes over the measurement points in the Infertility Questionnaire - Guilt/Blame subscale
It has 5 items measuring participants' tendency to blame oneself or partner for infertility. Scores range from 5 to 25, where a higher score represent greater tendency to blame oneself or partner for infertility.
Measured: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Changes over the measurement points in the 10-item Connor-Davidson Resilience Scale
It has 10 items measuring participants' positive adaptation in the face of adversity. Scores range from 0 to 40, where a higher score represents a higher level of resilience.
Measured: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Jul 2023 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 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 The University of Hong KongThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Celia Hoi-Yan Chan, The University of Hong Kong
- Investigators
- Celia Hoi-Yan Chan, PhD, Principal investigator, Department of Social Work and Social Administration, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091450
- Sponsor's protocol ID
- EA210488
- Status last verified
- Nov 2022
- First submitted
- 9 Oct 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Couple-Based Integrative Body-mind-spirit Group Intervention for Infertile Couples on Improving Dyadic Couple Flourishing and Fertility Quality of Life: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05091450
- Acronym / sponsor ID
- EA210488
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 Oct 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.
This is a two-arm, with equal randomization, parallel randomized controlled trial. It compares the efficacy of a couple-based Integrative Body-Mind-Spirit (I-BMS) group intervention to a waitlist control group in improving dyadic couple flourishing and fertility-related quality of life among couples who are diagnosed of infertility in Hong Kong. It also aims to investigate the dyadic associations between infertile husbands' and wives' baseline primary outcomes and changes in primary outcomes following the intervention.
Detailed description
Infertility is a global public health issue, affecting approximately 15% of childbearing-aged couples around the world. It is often a challenging dyadic life experience that generates adverse impacts on the psychosocial well-being of couples at childbearing age. Numerous psychosocial interventions have been developed for infertile women, and their efficacy and effectiveness were supported empirically. This study attempts to address the limitations incurred in existing psychosocial interventions for infertility by: (1) including infertile men and couples who have not sought fertility treatment and (2) incorporating relational outcomes within psychosocial interventions for infertile couples. This is a two-arm, with equal randomization, parallel randomized controlled trial. It compares the efficacy of a couple-based Integrative Body-Mind-Spirit (I-BMS) group intervention to a waitlist control group in improving dyadic couple flourishing and fertility-related quality of life among couples who are diagnosed of infertility in Hong Kong. It also aims to investigate the dyadic associations between infertile husbands' and wives' baseline primary outcomes and changes in primary outcomes following the intervention.
On hundred and seventy-eight infertile couples will be recruited through hospitals, clinics and local communities in Hong Kong. Each prospective couple will complete an online screening survey. Eligible couples will complete the baseline assessment, and then be randomized in a ratio of 1:1 into one of the two arms. Arm 1 is the couple-based I-BMS intervention for infertility, which consists of four 3-hour sessions within one month. Arm 2 is the waitlist control. Randomization will be performed by a computer. All eligible couples will be contacted by a research assistant for a pre-group interview prior to the commencement of the I-BMS intervention. The primary outcomes are changes over the measurement points in dyadic couple flourishing and fertility quality of life. The secondary outcomes include changes over the measurement points in empathy towards partner, partnership, relationship satisfaction, anxiety, depression, infertility-related blame, and resilience. Assessments are administered at baseline, post-intervention, 1-month follow-up, and 5-year follow-up. Structural equation modelling will be employed to examine the efficacy of the couple-based I-BMS intervention based on the intention-to-treat principle, as well as the dyadic association between infertile husbands' and wives' primary outcomes.
Eight hypotheses are generated. First, it is hypothesized that, after controlling for baseline dyadic couple flourishing, couples in the I-BMS intervention group will report significantly higher dyadic couple flourishing than their counterparts in the waitlist control group following the intervention. Second, it is hypothesized that, after controlling for post-intervention dyadic couple flourishing, couples in the I-BMS intervention group will report significantly higher dyadic couple flourishing than their counterparts in the waitlist control group at one-month follow-up. Third, it is hypothesized that, after controlling for baseline dyadic fertility quality of life, couples in the I-BMS intervention group will report significantly higher dyadic fertility quality of life than their counterparts in the waitlist control group following the intervention. Fourth, it is hypothesized that, after controlling for post-intervention dyadic fertility quality of life, couples in the I-BMS intervention group will report significantly higher dyadic fertility quality of life than their counterparts in the waitlist control group at one-month follow-up. Fifth, it is hypothesized that wives' baseline fertility quality of life is predicted by their own and their husbands' baseline couple flourishing. Sixth, it is hypothesized that husbands' baseline fertility quality of life is predicted by their own and their wives' baseline couple flourishing. Seventh, it is hypothesized that wives' post-intervention improvements in fertility quality of life is predicted by their own and their husbands' post-intervention improvements in couple flourishing. Eighth, it is hypothesized that husbands' post-intervention improvements in fertility quality of life is predicted by their own and their wives' post-intervention improvements in couple flourishing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couple-based I-BMS intervention for infertility | Experimental | Behavioral: Couple-based I-BMS intervention for infertilityThe I-BMS intervention will be conducted face-to-face and in group format. It comprises four 3-hour sessions within one month. Two registered social workers who are professionally trained on I-BMS intervention model will deliver the intervention. |
| Waitlist control | Other | Behavioral: Couple-based I-BMS intervention for infertilityCouples allocated in the waitlist control group will begin the I-BMS intervention (same as the intervention group) after completing the 1-month follow-up assessment. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- are in a heterosexual marriage
- are clinically diagnosed of infertility
- are actively trying to conceive
- are able to understand, read and speak Chinese
- age 18 or above
Key exclusion criteria (4 listed)
- are being exposed to intimate partner violence within the past 12 months (HARK test score >=1)
- have signs of early psychosis within the past 12 months (Screen for Early Psychosis score = 2)
- have suicidal ideation in the past 2 weeks (Beck Depression Inventory II, item 9, score >= 2)
- already have a living child or children
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 |
|---|---|---|
| Couple-based I-BMS intervention for infertilityIt is based on the previous I-BMS intervention for women undergoing IVF treatment, and aims to improve fertility quality of life and couple flourishing by (1) increasing awareness of the interconnectedness between physical and psychosocial well-being, (2) practicing body-mind-spirit techniques, (3) facilitating personal growth and partner empathy and compassion, and (3) creating the shared meaning of life, family, children. As a strength-focused and meaning-oriented approach, it utilizes experiential and self-reflective exercises to help participants reconstruct the meaning behind their ordeal and rediscover the strengths that keep them going. | Behavioural | Couple-based I-BMS intervention for infertility, Waitlist control |
Primary outcome
Changes over the measurement points in the Couple Flourishing Measure
Time frame: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
It has 16 items measuring participants' perceived encouragement towards expanding goals, recognition of partner's strengths, and engagement in meaningful activities with their partner. Scores range from 16 to 112, where a higher score represents a higher level of couple flourishing.
Changes over the measurement points in the Fertility Quality of Life Questionnaire - Core FertiQoL subscale
Time frame: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
It has 24 items measuring the consequences of fertility problems on quality of life over four life domains (emotional, mind/body, relational, and social). Subscale scores range from 0 to 100, where a higher score represent a higher level of fertility quality of life.
6 secondary outcomes
Changes over the measurement points in the Interpersonal Reactivity Index
Time frame: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Changes over the measurement points in the Relationship Flourishing Scale
Time frame: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Changes over the measurement points in the Brief Version of the Dyadic Adjustment Scale
Time frame: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Changes over the measurement points in the Hospital Anxiety and Depression Scale
Time frame: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Changes over the measurement points in the Infertility Questionnaire - Guilt/Blame subscale
Time frame: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Changes over the measurement points in the 10-item Connor-Davidson Resilience Scale
Time frame: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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. This study is not recruiting at the moment.
Celia Hoi-Yan Chan, PhD principal investigator
Department of Social Work and Social Administration, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couple-based I-BMS intervention for infertility in people with Infertility, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celia Hoi-Yan Chan, PhD ((852) 3917 2089, chancelia@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes over the measurement points in the Couple Flourishing Measure (time frame: Baseline, post-intervention: 4 weeks after the intervention initiation, 1-month follow-up, 5-year follow-up). The study lists 2 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 2 Nov 2022.