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OpenTrials
Completed

NCT Number: NCT01318291

Effect of Psychological Intervention on Drop-out Rates in IVF

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.

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston IVF

Waltham, Massachusetts, 02451, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CCRI Group

Behavioral

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

Behavioral

Medical treatment alone

Primary outcomes

  1. Drop out rates

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Boston IVF

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

An Assessment of the Effect of a Brief Psychological Intervention on Decreasing Drop-Out Rates in IVF Patients

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 18, 2011
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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