Communication With in Vitro Fertilization (IVF) Patients About Risks

November 22, 2016 updated by: University of Kansas Medical Center

Improving Communication With IVF Patients About Risks Such as Multiple Births

The primary objective of this trial is to determine whether written educational materials plus brief education by telephone will help patients better understand and participate in the decision on how many embryos to transfer to the uterus during treatment of infertility with in vitro fertilization (IVF). The main study hypothesis is that women and men who receive the study's educational intervention will experience favorable changes in knowledge and beliefs about benefits, susceptibility and severity of multiple gestation that impact decisions about the number of embryos to transfer. Secondary objectives are to understand patient beliefs, knowledge and information preferences regarding other possible risks of IVF, to compare perception of IVF-related risks to familiar risks that are included in routine preconception health promotion, and during IVF, and to prepare couples to manage IVF-related obstetrical risks when they make the transition to prenatal care after becoming pregnant.

Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The long-term objective of this research is to improve patient understanding of the known and strongly suspected risks from treating infertility with assisted reproductive technologies such as in vitro fertilization (IVF). During IVF, when more embryos are transferred to the uterus, the risk of pregnancy with multiple fetuses increases. In addition, single infants conceived with IVF are at greater risk for low birth weight. This study will promote behaviors that may reduce these risks. One in 3 women who completes a pregnancy conceived with assisted reproductive technologies such as IVF delivers multiples, and these treatments produce over 12,000 multiple birth deliveries annually in the United States. This study will lead to a better understanding of the most effective ways to counsel IVF patients about the embryo transfer decision. This study will also help define how to prepare IVF patients to work most effectively with their prenatal care team to manage IVF-related obstetrical risks.

Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Wichita, Kansas, United States, 67214
        • University of Kansas School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age

Exclusion Criteria:

  • Using a gestational carrier in the current cycle of IVF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Written materials, telephone based education
Behavioral: Written materials, telephone based education
4 new written materials, 15-20 minute educational session by telephone
Other: Comparison
Written materials
Other: Written materials
2 written materials available on public website

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
questionnaire assessing knowledge, risk perception, self efficacy and preferences, interview about risk perception and decision making
Time Frame: Prior to IVF treatment cycle, 8 weeks
Prior to IVF treatment cycle, 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adoption of healthy preconception behavior, self-efficacy for addressing IVF related obstetrical factors
Time Frame: Prior to IVF treatment cycle, 8 weeks
Prior to IVF treatment cycle, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Linda Frazier, MD, University of Kansas School of Medicine-Wichita

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 24, 2008

First Posted (Estimate)

July 25, 2008

Study Record Updates

Last Update Posted (Estimate)

November 25, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 220060957
  • 1R21HD053459-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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