Stress Management for Couples Undergoing In Vitro Fertilization (IVF)

Stress Management for Couples With Infertility Undergoing In Vitro Fertilization (IVF)

The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Behavioral: Stress Management & Resiliency Training; Behavioral: Stress Management DVD

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stress Management & Resiliency Training; 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.	Behavioral: Stress Management & Resiliency Training; 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.
Active Comparator: Stress Management DVD; The couples in this group will receive a Mayo Clinic Stress Management DVD.	Behavioral: Stress Management DVD; The couples in this group will receive a Mayo Clinic Stress Management DVD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical or biochemical miscarriage	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.	12 months after randomization

Collaborators and Investigators

• Sponsor: Amit Sood
• Investigators: Principal Investigator: Amit Sood, MD, Mayo Clinic; Study Chair: Zaraq Khan, MBBS, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Estimate): November 6, 2015
• Last Update Submitted That Met QC Criteria: November 5, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Infertility; Stress Management; Stress Reduction; In Vitro Fertilization (IVF)
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 12-007272