The Impact of Distress on the IVF Outcome

Boston IVF143 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

143

Conditions

Infertility

Interventions

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Presence of normal fetal heart rate and fetal size at 7 weeks gestation.

Time frame: 1 year

Secondary Outcomes

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.