Stress Management for Couples Undergoing In Vitro Fertilization (IVF)

Phase 2

Completed

• Conditions: Infertility
• Interventions: Behavioral: Stress Management & Resiliency Training; Behavioral: Stress Management DVD

• Registration Number: NCT01714882
• Lead Sponsor: Amit Sood

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-26
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-05
• Last Update Posted: 2015-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress Management & Resiliency Training	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.
Stress Management DVD	Stress Management DVD	The couples in this group will receive a Mayo Clinic Stress Management DVD.

Primary Outcome Measures

Name	Time	Method
Change of Scores from questionnaires from baseline to 6 and then 12 weeks	Baseline, 6 and 12 weeks after randomization	Primary outcome measure will be comparison of pre- and post-stress reduction treatment questionnaire scale scores.

Secondary Outcome Measures

Name	Time	Method
Clinical Pregnancy rate	12 months after randomization	Clinical pregnancy rate: which is defined as seeing a gestational sac in the uterus with a fetal pole that has a heart beat.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States