Stress Management for Couples Undergoing In Vitro Fertilization (IVF)
1 other identifier
interventional
60
1 country
1
Brief Summary
The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 18, 2012
CompletedFirst Posted
Study publicly available on registry
October 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedNovember 6, 2015
November 1, 2015
2.9 years
October 18, 2012
November 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Scores from questionnaires from baseline to 6 and then 12 weeks
Primary outcome measure will be comparison of pre- and post-stress reduction treatment questionnaire scale scores.
Baseline, 6 and 12 weeks after randomization
Secondary Outcomes (1)
Clinical Pregnancy rate
12 months after randomization
Other Outcomes (1)
Clinical or biochemical miscarriage
12 months after randomization
Study Arms (2)
Stress Management & Resiliency Training
EXPERIMENTALThe couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.
Stress Management DVD
ACTIVE COMPARATORThe couples in this group will receive a Mayo Clinic Stress Management DVD.
Interventions
The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.
The couples in this group will receive a Mayo Clinic Stress Management DVD.
Eligibility Criteria
You may qualify if:
- Women with clinical infertility, either primary or secondary, who are recommended for IVF for the first time as part of their treatment for infertility
- Women with a partner, and both are willing to provide consent for study participation as a couple
- Couples that can be reached by telephone for follow-up
You may not qualify if:
- Women less than 18 years of age
- Women equal or greater than 40 years of age
- Women with a history of recurrent pregnancy loss
- History of current or recent psychotic episode within past 6 months for either the woman or her partner
- Couples needing a interpreter for their clinical encounter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amit Soodlead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amit Sood, MD
Mayo Clinic
- STUDY CHAIR
Zaraq Khan, MBBS
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Medicine, Consultant - General Internal Medicine
Study Record Dates
First Submitted
October 18, 2012
First Posted
October 26, 2012
Study Start
October 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
November 6, 2015
Record last verified: 2015-11