The Impact of an Online Stress Management Program on IVF Outcome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Boston IVF
- Locations
- 1
- Primary Endpoint
- Clinical Pregnancy Rates
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Online Stress Management Group (Upliv) (Behavioral)
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.
Intervention: Control (Behavioral)
Outcomes
Primary Outcomes
Clinical Pregnancy Rates
Time Frame: 1 year
Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.
Secondary Outcomes
- Psychological Status(1 year)
Investigators
Alice D. Domar, PhD
Alice D. Domar, PhD
Boston IVF