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: Open Label
Primary Purpose: Treatment
|Official Title:||The Impact of Distress on the IVF Outcome|
- Clinical Pregnancy Rates [ Time Frame: 2 IVF Cycles ] [ Designated as safety issue: No ]Presence of normal fetal heart rate and fetal size at 7 weeks gestation.
- Psychological Status [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Psychological status is assessed by the following scales: Derogatis Affect Balance Scale (DABS), Perceived Stress Scale (PSS), State Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Fertility Problem Inventory (FPI), Infertility Self Efficacy Scale (ISES), Social Readjustment Scale (SRS), Short Form Health Survey (SF-36), Daily Monitoring Form (DMF). Other than the DMF, these are all published validated scales.
|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|