The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome
|ClinicalTrials.gov Identifier: NCT01156324|
Recruitment Status : Withdrawn (Loss of funding.)
First Posted : July 2, 2010
Last Update Posted : February 4, 2016
|Condition or disease||Intervention/treatment|
|Infertility||Behavioral: Online Stress Management Group (Upliv) Behavioral: Control|
The relationship between stress and infertility has remained a subject of controversy for many years. Recent research indicates that stress has a strong negative impact on pregnancy rates in women undergoing in vitro fertilization (IVF). In addition, stress is the most common reason given by women who voluntarily terminate treatment.
In a recent study, women who participated in a group mind/body treatment program had higher pregnancy rates than control subjects. The impact of an online stress management program has never been studied in the infertile population. An online intervention would be far more accessible for many infertility patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of an Online Stress Management Program on IVF Outcome|
|Study Start Date :||July 2010|
|Primary Completion Date :||August 2010|
|Study Completion Date :||August 2010|
Placebo Comparator: Control
Participants of the routine care control group will each receive a $50 gift certificate at the end of each IVF cycle for which they completed the questionnaires.
Behavioral: Online Stress Management Group (Upliv)
Personalized online stress management program
Experimental: Online Stress Management Group (Upliv)
Personalized online stress management program consisting of weekly sessions which each include relaxation exercises, stress management strategies, and lifestyle modification advice. Participants in Upliv will also be given a set of personal care products as part of the program.
Control group receiving routine care along with $50 gift certificate at end of cycle
- Clinical Pregnancy Rates [ Time Frame: 1 year ]Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.
- Psychological Status [ Time Frame: 1 year ]Psychological status is assessed by the following scales: Perceived Stress Scale (PSS), State Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Social Readjustment Scale (SRS), Daily Monitoring Form (DMF). Other than the DMF, these are all published validated scales.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156324
|United States, Massachusetts|
|Waltham, Massachusetts, United States, 02451|
|Principal Investigator:||Alice D Domar, PhD||Boston IVF|