Stress Management for Couples Undergoing In Vitro Fertilization (IVF)

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

Detailed Description
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Behavioral: Stress Management & Resiliency Training
* Behavioral: Stress Management DVD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, In Vitro Fertilization (IVF), Stress Management, Stress Reduction