Back to resultsThe Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome
Primary Purpose
Infertility
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Stress Management Group (Upliv)
Control
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring IVF, Stress management
Eligibility Criteria
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
Sites / Locations
- Boston IVF
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Online Stress Management Group (Upliv)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Clinical Pregnancy Rates
Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01156324
Brief Title
The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome
Official Title
The Impact of an Online Stress Management Program on IVF Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Loss of funding.
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston IVF
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, Stress management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Online Stress Management Group (Upliv)
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Online Stress Management Group (Upliv)
Intervention Description
Personalized online stress management program
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Control group receiving routine care along with $50 gift certificate at end of cycle
Primary Outcome Measure Information:
Title
Clinical Pregnancy Rates
Description
Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Psychological Status
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice D Domar, PhD
Organizational Affiliation
Boston IVF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston IVF
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome
We'll reach out to this number within 24 hrs