Stress Management for Couples Undergoing In Vitro Fertilization (IVF)

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714882
• Other study ID #: 12-007272
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2012
• Last updated: November 5, 2015
• Start date: October 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 39 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infertility

Intervention

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.
• Stress Management DVD
The couples in this group will receive a Mayo Clinic Stress Management DVD.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Amit Sood

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No