The Impact of Distress on the IVF Outcome
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 Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||The Impact of Distress on the IVF Outcome|
- Clinical Pregnancy Rates [ Time Frame: 1 year ]Presence of normal fetal heart rate and fetal size at 7 weeks gestation.
|Study Start Date:||March 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Placebo Comparator: Control (Spa Certificate)
For every three months in the study control subjects received $50 spa gift certificates.
Spa gift certificates
Experimental: Mind/Body Program
Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.
Behavioral: Mind/Body Program
Ten week group mind/body program
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103973
|United States, Massachusetts|
|Waltham, Massachusetts, United States, 02451|
|Principal Investigator:||Alice D Domar, PhD||Boston IVF|