Effect of Psychological Intervention on Drop-out Rates in IVF
NCT ID: NCT01318291
Last Updated: 2016-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
166 participants
INTERVENTIONAL
2011-04-30
2014-09-30
Brief Summary
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The objective of this study is to determine the efficacy of a combined Cognitive Coping and Relaxation Intervention (CCRI) in reducing drop out behavior in IVF patients.
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Detailed Description
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The relaxation components of the CCRI consists of techniques that have been used for two decades in the mind/body infertility program as well as in randomized controlled research trials. For the Stimulation phase, participants will receive instructions on how to do "mini relaxation" techniques which are specifically designed to reduce anxiety in the moment, for example feelings of tension, worry, and nervousness that might occur prior to and during Stimulation phase procedures (e.g. injections, blood tests, and ultrasounds). For the Waiting Phase the relaxation intervention will include a relaxation CD. The CD contains narrated instruction on how to elicit the relaxation response through several techniques
This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes women ages 44 and below scheduled to undergo their first IVF cycle. Subjects are randomized to a CCRI or a control group. The primary outcome measure is dropout rates.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Control
Control
Medical treatment alone
CCRI Group
CCRI Group
Cognitive Coping and Relaxation Intervention (CCRI) Cognitive Coping and Relaxation Intervention (CCRI) group who will receive a packet of relaxation and stress management suggestions
Interventions
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CCRI Group
Cognitive Coping and Relaxation Intervention (CCRI) Cognitive Coping and Relaxation Intervention (CCRI) group who will receive a packet of relaxation and stress management suggestions
Control
Medical treatment alone
Eligibility Criteria
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Inclusion Criteria
* Using own eggs
* Able to read, understand, and sign the informed consent in English
* Must have insurance coverage for IVF cycle
Exclusion Criteria
* Donor egg cycle
18 Years
44 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Boston IVF
OTHER
Responsible Party
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Alice D. Domar, PhD
Alice D. Domar, PhD
Principal Investigators
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Alice D Domar, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston IVF
Jacky Boivin, PhD
Role: STUDY_DIRECTOR
School of Psychology, Cardiff University
Locations
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Boston IVF
Waltham, Massachusetts, United States
Countries
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References
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Domar AD, Gross J, Rooney K, Boivin J. Exploratory randomized trial on the effect of a brief psychological intervention on emotions, quality of life, discontinuation, and pregnancy rates in in vitro fertilization patients. Fertil Steril. 2015 Aug;104(2):440-51.e7. doi: 10.1016/j.fertnstert.2015.05.009. Epub 2015 Jun 13.
Other Identifiers
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38844
Identifier Type: -
Identifier Source: org_study_id
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