Stress Management for Couples Undergoing In Vitro Fertilization (IVF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Amit Sood, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01714882
First received: October 18, 2012
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Infertility
Behavioral: Stress Management & Resiliency Training
Behavioral: Stress Management DVD
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Stress Management for Couples With Infertility Undergoing In Vitro Fertilization (IVF)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change of Scores from questionnaires from baseline to 6 and then 12 weeks [ Time Frame: Baseline, 6 and 12 weeks after randomization ] [ Designated as safety issue: No ]
    Primary outcome measure will be comparison of pre- and post-stress reduction treatment questionnaire scale scores.


Secondary Outcome Measures:
  • Clinical Pregnancy rate [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
    Clinical pregnancy rate: which is defined as seeing a gestational sac in the uterus with a fetal pole that has a heart beat.


Other Outcome Measures:
  • Clinical or biochemical miscarriage [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714882

Contacts
Contact: Kristi L Allen, BSN 507-293-3446 allen.kristi1@mayo.edu
Contact: Zaraq Khan, MBBS 507-284-4520 khan.Zaraq@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Amit Sood
Investigators
Principal Investigator: Amit Sood, MD Mayo Clinic
Principal Investigator: Zaraq Khan, MBBS Mayo Clinic
  More Information

No publications provided

Responsible Party: Amit Sood, Associate Professor of Medicine, Consultant - General Internal Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01714882     History of Changes
Other Study ID Numbers: 12-007272
Study First Received: October 18, 2012
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Infertility
In Vitro Fertilization (IVF)
Stress Management
Stress Reduction

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014