Study Stopped
Loss of funding.
The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedFirst Posted
Study publicly available on registry
July 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFebruary 4, 2016
February 1, 2016
1 month
June 29, 2010
February 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Pregnancy Rates
Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.
1 year
Secondary Outcomes (1)
Psychological Status
1 year
Study Arms (2)
Control
PLACEBO COMPARATORParticipants 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.
Online Stress Management Group (Upliv)
EXPERIMENTALPersonalized 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.
Interventions
Personalized online stress management program
Control group receiving routine care along with $50 gift certificate at end of cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- prescription antipsychotic medication
- previous diagnosis of borderline or narcissistic personality disorder
- previous or concurrent participation in a mind/body group
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston IVFlead
Study Sites (1)
Boston IVF
Waltham, Massachusetts, 02451, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice D Domar, PhD
Boston IVF
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Alice D. Domar, PhD
Study Record Dates
First Submitted
June 29, 2010
First Posted
July 2, 2010
Study Start
July 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
February 4, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share