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

This study has been withdrawn prior to enrollment.
(Loss of funding.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01156324
First Posted: July 2, 2010
Last Update Posted: February 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alice D. Domar, PhD, Boston IVF
  Purpose
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.

Condition Intervention
Infertility Behavioral: Online Stress Management Group (Upliv) Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of an Online Stress Management Program on IVF Outcome

Further study details as provided by Alice D. Domar, PhD, Boston IVF:

Primary Outcome Measures:
  • Clinical Pregnancy Rates [ Time Frame: 1 year ]
    Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.


Secondary Outcome Measures:
  • 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.


Enrollment: 0
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Control
Control group receiving routine care along with $50 gift certificate at end of cycle

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156324


Locations
United States, Massachusetts
Boston IVF
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Boston IVF
Investigators
Principal Investigator: Alice D Domar, PhD Boston IVF
  More Information

Responsible Party: Alice D. Domar, PhD, Boston IVF
ClinicalTrials.gov Identifier: NCT01156324     History of Changes
Other Study ID Numbers: 20100765
First Submitted: June 29, 2010
First Posted: July 2, 2010
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alice D. Domar, PhD, Boston IVF:
IVF
Stress management

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female