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Effect of Psychological Intervention on Drop-out Rates in IVF

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Alice D. Domar, PhD, Boston IVF Identifier:
First received: March 16, 2011
Last updated: February 3, 2016
Last verified: February 2016

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.

Condition Intervention
Infertility Behavioral: CCRI Group Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: An Assessment of the Effect of a Brief Psychological Intervention on Decreasing Drop-Out Rates in IVF Patients

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

Primary Outcome Measures:
  • Drop out rates [ Time Frame: 12 months ]

Enrollment: 166
Study Start Date: April 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Behavioral: Control
Medical treatment alone
Experimental: CCRI Group Behavioral: 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

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.


Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01318291

United States, Massachusetts
Boston IVF
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Boston IVF
Merck Sharp & Dohme Corp.
Principal Investigator: Alice D Domar, PhD Boston IVF
Study Director: Jacky Boivin, PhD School of Psychology, Cardiff University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alice D. Domar, PhD, Boston IVF Identifier: NCT01318291     History of Changes
Other Study ID Numbers: 38844
Study First Received: March 16, 2011
Last Updated: February 3, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alice D. Domar, PhD, Boston IVF:
Drop out

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female processed this record on August 22, 2017