Clinical trial NCT01318291: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: IVF
Drop out
Lead sponsor: Boston IVF
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-03-18
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Drop out rates
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
Study officials:
affiliation: Boston IVF
name: Alice D Domar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Psychology, Cardiff University
name: Jacky Boivin, PhD
role: STUDY_DIRECTOR
References:
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.