- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01156324
The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome
The Impact of an Online Stress Management Program on IVF Outcome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Waltham, Massachusetts, United States, 02451
- Boston IVF
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Control group receiving routine care along with $50 gift certificate at end of cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Pregnancy Rates
Time Frame: 1 year
|
Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alice D Domar, PhD, Boston IVF
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20100765
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Sapientiae InstituteTerminated
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
King's College LondonNot yet recruitingInfertility | Infertility, Female | Infertility Unexplained | Infertility of Tubal Origin
-
Gazi UniversityCompletedMale Infertility | Unexplained Infertility
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMale Infertility, AzoospermiaUnited States
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Istanbul University - Cerrahpasa (IUC)RecruitingInfertility | Sexual Dysfunction | Infertility, Male | Nurse's Role | Sexuality | Infertility; FemaleTurkey
Clinical Trials on Online Stress Management Group (Upliv)
-
University Hospital, Basel, SwitzerlandSwiss National Science Foundation; Krebsforschung Schweiz, Bern, SwitzerlandCompletedCancer | Psychological DistressSwitzerland
-
Massachusetts General HospitalNational Center for Complementary and Integrative Health (NCCIH)CompletedStress, Psychological | Stress, PhysiologicalUnited States
-
Massachusetts General HospitalThe Children's Tumor FoundationCompletedNeurofibromatosis 2United States
-
Massachusetts General HospitalThe Children's Tumor FoundationCompletedNeurofibromatosesUnited States
-
Oregon Center for Applied Science, Inc.Completed
-
The Cleveland ClinicCompletedDepression | Anxiety | Psychological StressUnited States
-
Albert Einstein College of MedicineAmerican Cancer Society, Inc.Completed
-
St. Mary's Research Center, CanadaMcGill UniversityCompletedCardiovascular Diseases | Stress, PsychologicalCanada
-
University of MiamiNational Cancer Institute (NCI)Completed
-
Hong Kong Baptist UniversityStockholm University; Research Grants Council, Hong KongCompletedPsychological DistressHong Kong