Effect of Psychological Intervention on Drop-out Rates in IVF

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Alice D. Domar, PhD, Boston IVF
ClinicalTrials.gov Identifier:
NCT01318291
First received: March 16, 2011
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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 Blind (Caregiver)
Primary Purpose: Treatment
Official Title: An Assessment of the Effect of a Brief Psychological Intervention on Decreasing Drop-Out Rates in IVF Patients

Resource links provided by NLM:


Further study details as provided by Boston IVF:

Primary Outcome Measures:
  • Drop out rates [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  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: NCT01318291

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

No publications provided

Responsible Party: Alice D. Domar, PhD, Boston IVF
ClinicalTrials.gov Identifier: NCT01318291     History of Changes
Other Study ID Numbers: 38844
Study First Received: March 16, 2011
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston IVF:
IVF
Drop out

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

ClinicalTrials.gov processed this record on August 28, 2014