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The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress Management & Resiliency Training | Experimental | 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 | Active Comparator | The couples in this group will receive a Mayo Clinic Stress Management DVD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress Management & Resiliency Training | Behavioral | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Sood, MD | Mayo Clinic | Principal Investigator |
| Zaraq Khan, MBBS | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Stress Management DVD | Behavioral | The couples in this group will receive a Mayo Clinic Stress Management DVD. |
|