Effect of Psychological Intervention on Drop-out Rates in IVF
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CCRI Group
Control
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring IVF, Drop out
Eligibility Criteria
Inclusion Criteria:
- First fresh IVF cycle
- Using own eggs
- Able to read, understand, and sign the informed consent in English
- Must have insurance coverage for IVF cycle
Exclusion Criteria:
- >1 previous IVF cycle
- Donor egg cycle
Sites / Locations
- Boston IVF
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
CCRI Group
Arm Description
Outcomes
Primary Outcome Measures
Drop out rates
Secondary Outcome Measures
Full Information
NCT ID
NCT01318291
First Posted
March 16, 2011
Last Updated
February 3, 2016
Sponsor
Boston IVF
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01318291
Brief Title
Effect of Psychological Intervention on Drop-out Rates in IVF
Official Title
An Assessment of the Effect of a Brief Psychological Intervention on Decreasing Drop-Out Rates in IVF Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston IVF
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The most common reason why insured In Vitro Fertilization (IVF) patients drop out of treatment is the distress caused by the treatment.
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.
Detailed Description
Intervention participants will be given a packet containing the CCRI, which consists of two intervention components tailored to the Stimulation Phase and Waiting Phases of IVF. The cognitive component of the CCRI is the PRCI intervention (Boivin & Lancastle, 2008) tailored to the stimulation/waiting phases of an IVF cycle. The PRCI intervention consists of a series of ten statements that facilitate the use of cognitive reappraisal coping, a form of coping that helps people think more about the positive aspects of a difficult situation and dwell less on problems or uncertainties of the future.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, Drop out
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
CCRI Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
CCRI Group
Intervention Description
Cognitive Coping and Relaxation Intervention (CCRI) Cognitive Coping and Relaxation Intervention (CCRI) group who will receive a packet of relaxation and stress management suggestions
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Medical treatment alone
Primary Outcome Measure Information:
Title
Drop out rates
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
First fresh IVF cycle
Using own eggs
Able to read, understand, and sign the informed consent in English
Must have insurance coverage for IVF cycle
Exclusion Criteria:
>1 previous IVF cycle
Donor egg cycle
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice D Domar, PhD
Organizational Affiliation
Boston IVF
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacky Boivin, PhD
Organizational Affiliation
School of Psychology, Cardiff University
Official's Role
Study Director
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
Citations:
PubMed Identifier
26072382
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Psychological Intervention on Drop-out Rates in IVF
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