The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome

Study Overview
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Brief Summary
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The goal of this study is to determine the impact of an online stress management program, which combines stress reduction and prevention strategies with personal care products/rituals which have relaxation properties, on pregnancy rates and psychological distress in women undergoing IVF for the first time.

Detailed Description
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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.

Official Title
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The Impact of an Online Stress Management Program on IVF Outcome

Conditions
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Infertility

Intervention / Treatment
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* Behavioral: Online Stress Management Group (Upliv)
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female Boston IVF patients day three FSH 12 or below day three estradiol 80 pg/ml or below able to read, understand and sign the informed consent in English using own eggs (not egg donor) willing and able to comply with study requirements must be well versed in using a personal computer and the internet and must have access to an internet-connected computer seven days per week Exclusion Criteria: prescription antipsychotic medication previous diagnosis of borderline or narcissistic personality disorder previous or concurrent participation in a mind/body group

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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)<br>* Personalized online stress management program<br>|
| Experimental: Online Stress Management Group (Upliv)<br>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. | Behavioral: Control<br>* Control group receiving routine care along with $50 gift certificate at end of cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy Rates | Clinical pregnancy rates will be recorded for IVF cycles 1 and 2. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Status | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Stress management