Infertility Clinical Trial
Official title:
The Impact of Distress on the IVF Outcome
Verified date | December 2017 |
Source | Boston IVF |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 143 |
Est. completion date | November 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 40 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston IVF | Waltham | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston IVF |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Pregnancy Rates | Presence of normal fetal heart rate and fetal size at 7 weeks gestation. | 1 year | |
Secondary | Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) | Psychological status is assessed by the Beck Depression Inventory (BDI). The scores range from 0 to 63; a score of 0 being no depression and 63 being severely depressed. Our cut-off for normal was a score of 12 or less, and those with a score of 13 or greater were considered to have symptoms of depression. | 1 year |
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