Infertility
Conditions
Keywords
Infertility, In Vitro Fertilization (IVF), Stress Management, Stress Reduction
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.
Interventions
BEHAVIORALStress 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.
BEHAVIORALStress Management DVD
The couples in this group will receive a Mayo Clinic Stress Management DVD.
Sponsors
Amit Sood
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical or biochemical miscarriage | 12 months after randomization | 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. |
Countries
United States
Outcome results
None listed