Communication With in Vitro Fertilization (IVF) Patients... | NCT00722618

Studies
Communication With in Vitro Fertilization (IVF) Patients About Risks

NCT00722618

Sponsor

University of Kansas Medical Center

Status

Completed

Last Update Posted

Nov 25, 2016Estimated

Enrollment

264Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Written materials, telephone based education
Written materials

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R21HD053459-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Feb 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jul 23, 2008

First Submission Date that Met QC Criteria

Jul 24, 2008

First Posted Date

Jul 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2016

Last Update Posted Date

Nov 25, 2016Estimated

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

264Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator	Written materials, telephone based education	Behavioral: Written materials, telephone based education
Comparison	Other	Written materials	Other: Written materials

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Written materials, telephone based education	Behavioral	4 new written materials, 15-20 minute educational session by telephone	Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age

Exclusion Criteria:

Using a gestational carrier in the current cycle of IVF

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Linda Frazier, MD	University of Kansas School of Medicine-Wichita	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas School of Medicine		Wichita	Kansas	67214	United States

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided