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Communication With in Vitro Fertilization (IVF) Patients About Risks

NCT ID: NCT00722618

Last Updated: 2016-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-05-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Infertility

Keywords

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

Written materials, telephone based education

Group Type ACTIVE_COMPARATOR

Written materials, telephone based education

Intervention Type BEHAVIORAL

4 new written materials, 15-20 minute educational session by telephone

Comparison

Written materials

Group Type OTHER

Written materials

Intervention Type OTHER

2 written materials available on public website

Interventions

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Written materials, telephone based education

4 new written materials, 15-20 minute educational session by telephone

Intervention Type BEHAVIORAL

Written materials

2 written materials available on public website

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age

Exclusion Criteria

* Using a gestational carrier in the current cycle of IVF
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda Frazier, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas School of Medicine-Wichita

Locations

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University of Kansas School of Medicine

Wichita, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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1R21HD053459-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

220060957

Identifier Type: -

Identifier Source: org_study_id