Primary InfertilityNCT05903638
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
A study testing Mindfulness-Based Stress Reduction course in people with Primary Infertility and Mental Health Issue, run by One Fertility at 1 site in Canada.
Trial summary
We plan to perform a pilot study in which women with primary infertility seeking an initial fertility consultation will be randomized into either a standard treatment group or an 8-week virtual Mindfulness-Based Stress Reduction (MBSR) program. Primary outcomes included retention and survey completion rates. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Infertility, Mental Health Issue, Quality of Life
- What is being tested?
- Mindfulness-Based Stress Reduction course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2022to 30 Sep 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Primary infertility and no prior fertility treatment
Who cannot join
- No internet access
- Non-English speaking
- History of suicidal ideation/intent, psychotic disorder, eating disorder, substance abuse or dependence, PTSD
- Psychotropic medication change in the previous month
- Previously seen at another fertility clinic
- Previous MBSR course
- Previous mindfulness meditation retreat
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility Seeking Fertility Treatment at a Single Centre
We plan to perform a pilot study in which women with primary infertility seeking an initial fertility consultation will be randomized into either a standard treatment group or an 8-week virtual Mindfulness-Based Stress Reduction (MBSR) program. Primary outcomes included retention and survey completion rates. Secondary outcomes included Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Perceived Stress Score (PSS), Fertility Problem Index (FPI), pregnancy rates, intention to pursue treatment and % pursuing treatment.
- Conditions
- Primary Infertility, Mental Health Issue, Quality of Life
- Being tested
- Mindfulness-Based Stress Reduction course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction courseBehavioural
Also called MBSR
8-week, 26-hour, virtual mindfulness course
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Virtual Mindfulness-Based Stress Reduction (MBSR) program | Experimental | Not described Receives: Behavioral: Mindfulness-Based Stress Reduction course |
What is being measured
The primary outcome is the main question the study is designed to answer.
MBSR course participation rate
Measured: 8-weeks of MBSR course
Survey completion rate
Measured: Randomization to 3-months after course completion
Secondary outcomes (6)
Beck Depression Inventory
Measured: Randomization to 3-months after course completion
Beck Anxiety Inventory
Measured: Randomization to 3-months after course completion
Perceived Stress Scale
Measured: Randomization to 3-months after course completion
Fertility Problem Inventory
Measured: Randomization to 3-months after course completion
% involvement in fertility treatment
Measured: 3-months after course completion
Pregnancy rates
Measured: 3-months after course completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start30 Sep 2022
- Primary completion31 Mar 2023
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InfertilityStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blinded pilot randomized control trial with control arm and intervention (virtual MBSR course).
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- One Fertility
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehrnoosh Faghih, MD, Principal investigator, McMaster University, ONE Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903638
- Sponsor's protocol ID
- MBSR Pilot RCT
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 15 Jun 2023
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility Seeking Fertility Treatment at a Single Centre
- ClinicalTrials.gov ID
- NCT05903638
- Acronym / sponsor ID
- MBSR Pilot RCT
- Conditions
- Primary Infertility, Mental Health Issue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- One FertilityUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 15 Jun 2023 (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.
We plan to perform a pilot study in which women with primary infertility seeking an initial fertility consultation will be randomized into either a standard treatment group or an 8-week virtual Mindfulness-Based Stress Reduction (MBSR) program. Primary outcomes included retention and survey completion rates. Secondary outcomes included Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Perceived Stress Score (PSS), Fertility Problem Index (FPI), pregnancy rates, intention to pursue treatment and % pursuing treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blinded pilot randomized control trial with control arm and intervention (virtual MBSR course).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Virtual Mindfulness-Based Stress Reduction (MBSR) program | Experimental | Behavioral: Mindfulness-Based Stress Reduction course |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Primary infertility and no prior fertility treatment
Key exclusion criteria (7 listed)
- No internet access
- Non-English speaking
- History of suicidal ideation/intent, psychotic disorder, eating disorder, substance abuse or dependence, PTSD
- Psychotropic medication change in the previous month
- Previously seen at another fertility clinic
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 |
|---|---|---|
| Mindfulness-Based Stress Reduction courseAlso: MBSR8-week, 26-hour, virtual mindfulness course | Behavioural | Virtual Mindfulness-Based Stress Reduction (MBSR) program |
Primary outcome
MBSR course participation rate
Time frame: 8-weeks of MBSR course
Survey completion rate
Time frame: Randomization to 3-months after course completion
6 secondary outcomes
Beck Depression Inventory
Time frame: Randomization to 3-months after course completion
Beck Anxiety Inventory
Time frame: Randomization to 3-months after course completion
Perceived Stress Scale
Time frame: Randomization to 3-months after course completion
Fertility Problem Inventory
Time frame: Randomization to 3-months after course completion
% involvement in fertility treatment
Time frame: 3-months after course completion
Pregnancy rates
Time frame: 3-months after course completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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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. This study is not recruiting at the moment.
Mehrnoosh Faghih, MD principal investigator
McMaster University, ONE Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction course in people with Primary Infertility and Mental Health Issue, run by One Fertility at 1 site in Canada.
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 1 inclusion and 7 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 15 Jun 2023. 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 Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MBSR course participation rate (time frame: 8-weeks of MBSR course). 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 15 Jun 2023.