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Communication With in Vitro Fertilization (IVF) Patients About Risks

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by University of Kansas.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00722618
First received: July 23, 2008
Last updated: April 14, 2010
Last verified: April 2010
History of Changes
  Purpose

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


Condition Intervention
Infertility
 Behavioral: Written materials, telephone based education
Other: Written materials

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Improving Communication With IVF Patients About Risks Such as Multiple Births

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adoption of healthy preconception behavior, self-efficacy for addressing IVF related obstetrical factors [ Time Frame: Prior to IVF treatment cycle, 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: September 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Written materials, telephone based education
 Behavioral: Written materials, telephone based education
4 new written materials, 15-20 minute educational session by telephone
2
Written materials
 Other: Written materials
2 written materials available on public website

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Not using a gestational carrier in the current cycle of IVF
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722618

Locations
United States, Kansas
University of Kansas School of Medicine
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
University of Kansas
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Linda Frazier, MD University of Kansas School of Medicine-Wichita
  More Information

No publications provided

Responsible Party: Linda Frazier MD, University of Kansas School of Medicine - Wichita
ClinicalTrials.gov Identifier: NCT00722618     History of Changes
Other Study ID Numbers: 220060957, 1R21HD053459-01A1
Study First Received: July 23, 2008
Last Updated: April 14, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 16, 2013