The Impact of Distress on the IVF Outcome
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|ClinicalTrials.gov Identifier: NCT01103973|
Recruitment Status : Completed
First Posted : April 15, 2010
Results First Posted : October 24, 2016
Last Update Posted : January 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Behavioral: Mind/Body Program Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Distress on the IVF Outcome|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||November 2009|
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
- Clinical Pregnancy Rates [ Time Frame: 1 year ]Presence of normal fetal heart rate and fetal size at 7 weeks gestation.
- Pregnancy Rate Based on Psychological Status Assessed by the Beck Depression Inventory (BDI) [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103973
|United States, Massachusetts|
|Waltham, Massachusetts, United States, 02451|
|Principal Investigator:||Alice D Domar, PhD||Boston IVF|