NCT01318291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

3.4 years

First QC Date

March 16, 2011

Last Update Submit

February 3, 2016

Conditions

Infertility

Keywords

IVFDrop out

Outcome Measures

Primary Outcomes (1)

  • Drop out rates

    12 months

Study Arms (2)

Control

PLACEBO COMPARATOR
Behavioral: Control

CCRI Group

EXPERIMENTAL
Behavioral: CCRI Group

Interventions

CCRI GroupBEHAVIORAL

Cognitive Coping and Relaxation Intervention (CCRI) Cognitive Coping and Relaxation Intervention (CCRI) group who will receive a packet of relaxation and stress management suggestions

CCRI Group
ControlBEHAVIORAL

Medical treatment alone

Control

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \>1 previous IVF cycle
  • Donor egg cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

Related Publications (1)

  • 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.

    PMID: 26072382DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Alice D Domar, PhD

    Boston IVF

    PRINCIPAL INVESTIGATOR

  • Jacky Boivin, PhD

    School of Psychology, Cardiff University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alice D. Domar, PhD

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 18, 2011

Study Start

April 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 4, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)