The Impact of Distress on the IVF Outcome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Boston IVF
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- Clinical Pregnancy Rates
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Stress is a primary reason why in vitro fertilization (IVF) patients drop out of treatment, and it may have a detrimental impact on pregnancy rates, yet there is minimal published research on the efficacy of structured skills-based psychological interventions with assisted reproductive technology (ART) patients. The objective of this study is to determine if women who are randomized to a mind/body (MB) program prior to starting their first IVF cycle will have higher pregnancy rates than controls (C).
This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes 143 women ages 40 and below scheduled to undergo their first IVF cycle. Subjects are randomized via computer generated random numbers table to a 10 session mind/body program or a control group and followed for two IVF cycles. The primary outcome measure is clinical pregnancy rate.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female Boston IVF infertility patient
- •Age 21-40 years
- •Day 3 FSH level 12 mIU/ml or below
- •Day 3 E2 level 80 pg/ml or below
- •Using own eggs (not an egg donor)
- •Daily access to the internet
- •Able to read, understand, and sign the informed consent in English
Exclusion Criteria
- •Prescription antipsychotic medication
- •Diagnosis of borderline or narcissistic personality disorder
- •Previous participation in a MB group
Outcomes
Primary Outcomes
Clinical Pregnancy Rates
Time Frame: 1 year
Presence of normal fetal heart rate and fetal size at 7 weeks gestation.
Secondary Outcomes
- Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI)(1 year)