NCT01546324

Brief Summary

The purpose of this study is to collect blood samples from pregnant women who achieved pregnancy following in-vitro fertilization (IVF) with Natera's preimplantation aneuploidy screening (with or without single gene gene testing). These samples will be used for test development of non-invasive prenatal diagnostic testing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

3 months

First QC Date

February 24, 2012

Last Update Submit

August 8, 2013

Conditions

Pregnancy Following IVF With PGS/PGD

Keywords

Maternal BloodPGDPGSNateraGene Security NetworkNon-invasive prenatal diagnosis

Outcome Measures

Primary Outcomes (1)

  • Collection of 500 maternal blood samples to be used for development of non-invasive prenatal diagnostic testing.

    1 year

Study Arms (1)

Pregnant women

Women pregnant following the use of Natera's PGS/PGD testing

Procedure: Blood draw

Interventions

Blood drawPROCEDURE

Maternal blood draw at approximately 8-17 weeks gestation.

Pregnant women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women 18 years of age or older who used Natera (formerly Gene Security Network)'s Preimplantation Genetic testing (PGS/PGD) to achieve their current pregnancy.

You may qualify if:

  • Pregnant women willing to donate a blood sample during the first or second trimester of their pregnancy (approximately 8-17 weeks gestation)
  • Use of Natera (formerly Gene Security Network)'s commercial preimplantation genetic testing (PGS/PGD)to achieve the current pregnancy

You may not qualify if:

  • Pregnant women who did not use Natera (formerly Gene Security Network)'s PGS/PGD testing to achieve their current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natera, Inc

Redwood City, California, 94063, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Matthew Rabinowitz, PhD

    CEO, Natera, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2012

First Posted

March 7, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Study Completion

August 1, 2013

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations

US(1)