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

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 Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Mental Health Issue; Primary Infertility
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction course

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L7N 3T1
      • ONE Fertility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Virtual Mindfulness-Based Stress Reduction (MBSR) program	Behavioral: Mindfulness-Based Stress Reduction course; 8-week, 26-hour, virtual mindfulness course; Other Names: MBSR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: One Fertility
• Investigators: Principal Investigator: Mehrnoosh Faghih, MD, McMaster University, ONE Fertility

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: MBSR Pilot RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No