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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Alice D. Domar, PhD, Boston IVF
ClinicalTrials.gov Identifier:
NCT01156324
First received: June 29, 2010
Last updated: September 4, 2012
Last verified: September 2012
  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: Open Label
Primary Purpose: Treatment
Official Title: The Impact of an Online Stress Management Program on IVF Outcome

Resource links provided by NLM:


Further study details as provided by Boston IVF:

Primary Outcome Measures:
  • Clinical Pregnancy Rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.


Secondary Outcome Measures:
  • Psychological Status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alice D. Domar, PhD, Boston IVF
ClinicalTrials.gov Identifier: NCT01156324     History of Changes
Other Study ID Numbers: 20100765
Study First Received: June 29, 2010
Last Updated: September 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Boston IVF:
IVF
Stress management

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

ClinicalTrials.gov processed this record on August 26, 2014