Evaluation of Fetal Sex in Assisted Reproductive Technolo... | NCT01021085

Studies
Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies

NCT01021085

Sponsor

Sequenom, Inc.

Status

Completed

Last Update Posted

Sep 5, 2011Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Fetal Sex Determination

Interventions

Not provided

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

Status Module

Record Verification Date

Sep 2011

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

Apr 2009

Primary Completion Date

Aug 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Oct 29, 2009

First Submission Date that Met QC Criteria

Nov 25, 2009

First Posted Date

Nov 26, 2009Estimated

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

Sep 1, 2011

Last Update Posted Date

Sep 5, 2011Estimated

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

Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56 days as confirmed by artificial reproductive technology (ART). The samples will be used to develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal plasma or urine.

Detailed Description

This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw and urine collection will occur between 36-42, 43-49, and 50-56 days gestation. The fetal gender will be requested at or soon after delivery. The accuracy of the test and the optimal time to perform the test during pregnancy will be assessed by comparing the test results from maternal blood and/or urine samples obtained between days 36 and 56 of gestation to the fetal sex results obtained at birth.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pregnant women		Pregnant women who have conceived via ART and are between days 36 and 56 of gestation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Develop a prenatal sex test using blood and/or urine samples from pregnant women.		36 to 56 days of gestation

Secondary Outcomes

Measure	Description	Time Frame
Establish the earliest time point between days 36 and 56 of gestation that the prenatal sex test has optimal performance.		36 to 56 days of gestation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is 18-45 years of age inclusive
Subject is female
Subject is pregnant
Gestational age can be determined via IVF or IUI
Subject is 36-42 days pregnant as determined by IVF transfer or IUI
Subject agrees to provide 3 separate blood and urine samples

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women who are pregnant via assisted reproductive technology between days 36 and 56 gestational age

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Allan Bombard, MD MBA	Sequenom, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
San Diego Fertility Center		San Diego	California	92130	United States
Fertility Centers of Illinois