A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility

A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility Seeking Fertility Treatment at a Single Centre

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05903638

Enrollment

Registered

2023-06-15

Start date

2022-09-30

Completion date

2023-09-30

Last updated

2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health Issue, Primary Infertility, Quality of Life

Brief 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. 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.

Interventions

BEHAVIORALMindfulness-Based Stress Reduction course

8-week, 26-hour, virtual mindfulness course

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Single-blinded pilot randomized control trial with control arm and intervention (virtual MBSR course).

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

-Primary infertility and no prior fertility treatment

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
MBSR course participation rate	8-weeks of MBSR course
Survey completion rate	Randomization to 3-months after course completion

Secondary

Measure	Time frame
Beck Depression Inventory	Randomization to 3-months after course completion
Fertility Problem Inventory	Randomization to 3-months after course completion
Beck Anxiety Inventory	Randomization to 3-months after course completion
Pregnancy rates	3-months after course completion
% involvement in fertility treatment	3-months after course completion
Perceived Stress Scale	Randomization to 3-months after course completion

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026