Communication With in Vitro Fertilization (IVF) Patients About Risks

Infertility Clinical Trial

Official title:

Improving Communication With IVF Patients About Risks Such as Multiple Births

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722618
• Other study ID #: 220060957
• Secondary ID: 1R21HD053459-01A
• Status: Completed
• Phase: N/A
• First received: July 23, 2008
• Last updated: November 22, 2016
• Start date: September 2007
• Est. completion date: May 2010

Study information

• Verified date: November 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: May 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

Exclusion Criteria:

• Using a gestational carrier in the current cycle of IVF

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Infertility

Intervention

Behavioral:
• Written materials, telephone based education
4 new written materials, 15-20 minute educational session by telephone

Other:
• Written materials
2 written materials available on public website

Locations

Country	Name	City	State
United States	University of Kansas School of Medicine	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	questionnaire assessing knowledge, risk perception, self efficacy and preferences, interview about risk perception and decision making		Prior to IVF treatment cycle, 8 weeks	No
Secondary	Adoption of healthy preconception behavior, self-efficacy for addressing IVF related obstetrical factors		Prior to IVF treatment cycle, 8 weeks	No