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

NCT05903638 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-06-15

No results posted yet for this study

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.

Conditions

  • Primary Infertility
  • Mental Health Issue
  • Quality of Life

Interventions

BEHAVIORAL

Mindfulness-Based Stress Reduction course

8-week, 26-hour, virtual mindfulness course

Sponsors & Collaborators

  • One Fertility

    lead OTHER

Principal Investigators

  • Mehrnoosh Faghih, MD · McMaster University, ONE Fertility

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-03-31
Completion
2023-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05903638 on ClinicalTrials.gov