Stress Management for Couples Undergoing In Vitro Fertilization (IVF)

Amit Sood

Status and phase: Completed; Phase 2

Conditions: Infertility

Treatments: Behavioral: Stress Management DVD; Behavioral: Stress Management & Resiliency Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01714882

12-007272

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Stress Management & Resiliency Training

Experimental group

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.

Treatment:

Behavioral: Stress Management & Resiliency Training

Stress Management DVD

Active Comparator group

Description:

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

Treatment:

Behavioral: Stress Management DVD