Back to resultsStress Management for Couples Undergoing In Vitro Fertilization (IVF)
Primary Purpose
Infertility
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stress Management & Resiliency Training
Stress Management DVD
Sponsored by
About this trial
This is an interventional prevention trial for Infertility focused on measuring Infertility, In Vitro Fertilization (IVF), Stress Management, Stress Reduction
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stress Management & Resiliency Training
Stress Management DVD
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Clinical Pregnancy rate
Clinical pregnancy rate: which is defined as seeing a gestational sac in the uterus with a fetal pole that has a heart beat.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01714882
Brief Title
Stress Management for Couples Undergoing In Vitro Fertilization (IVF)
Official Title
Stress Management for Couples With Infertility Undergoing In Vitro Fertilization (IVF)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amit Sood
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).
Detailed Description
The investigators are trying to determine two different stress management techniques in couples undergoing IVF. One arm will be randomized to learning these techniques by themselves by watching and following instructions on a digital video disc (DVD). The other arm will have an in-person class that will teach the couples different stress reduction techniques.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, In Vitro Fertilization (IVF), Stress Management, Stress Reduction
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stress Management & Resiliency Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Stress Management DVD
Arm Type
Active Comparator
Arm Description
The couples in this group will receive a Mayo Clinic Stress Management DVD.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management & Resiliency Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management DVD
Intervention Description
The couples in this group will receive a Mayo Clinic Stress Management DVD.
Primary Outcome Measure Information:
Title
Change of Scores from questionnaires from baseline to 6 and then 12 weeks
Description
Primary outcome measure will be comparison of pre- and post-stress reduction treatment questionnaire scale scores.
Time Frame
Baseline, 6 and 12 weeks after randomization
Secondary Outcome Measure Information:
Title
Clinical Pregnancy rate
Description
Clinical pregnancy rate: which is defined as seeing a gestational sac in the uterus with a fetal pole that has a heart beat.
Time Frame
12 months after randomization
Other Pre-specified Outcome Measures:
Title
Clinical or biochemical miscarriage
Description
Miscarriage will be defined as a biochemical or clinical miscarriage. A biochemical miscarriage will include a rise and then subsequent fall in beta human chorionic gonadotrophin (BhCG) to less than 5 IU/L. A clinical miscarriage will be defined as vaginal bleeding with passage of products of conception recognized as products of conception by histopathology.
Time Frame
12 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Sood, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zaraq Khan, MBBS
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stress Management for Couples Undergoing In Vitro Fertilization (IVF)
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