NCT01574404

Brief Summary

People with infertility undergoing in vitro fertilization (IVF) can test the embryos using a method called preimplantation genetic screening (PGS) before they are implanted in the uterus to possibly increase their chances of having a successful pregnancy. One or more cells are removed from the embryo. The chromosomes inside the cells are then tested to identify normal or aneuploid embryo(s). The investigators propose to evaluate a test called micro array analysis on the chromosomes of the first polar body. This method tests part of the egg that would normally be lost and may help us choose the embryo most likely to become a healthy baby.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

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

September 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 11, 2015

Status Verified

June 1, 2015

Enrollment Period

10 months

First QC Date

March 16, 2012

Last Update Submit

June 10, 2015

Conditions

Aneuploidy

Keywords

PGS,PGD, IVF, Polar Body Biopsy, FISH, Microarray analysis

Outcome Measures

Primary Outcomes (1)

  • Efficacy of polar biopsy and preimplantation genetic analysis

    To determine the efficacy of PB biopsy and analysis by comparing the PB results to the FISH/microarray results

    1 year

Secondary Outcomes (1)

  • Safety of polar biopsy

    1 year

Study Arms (1)

Polar Body Biopsy with PGS

EXPERIMENTAL

Polar Body Biopsy with Pre implantation genetic screening

Procedure: Polar body biopsy with PGS

Interventions

Polar body biopsy with PGSPROCEDURE

PB biopsy and analysis by comparing the PB results to the FISH/microarray results

Polar Body Biopsy with PGS

Eligibility Criteria

Age18 Years - 42 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Are undergoing IVF/Intracytoplasmic sperm injection(ICSI)
  • Are considering preimplantation genetic screening for aneuploidy
  • Are between ages 18 and 42 inclusive (female partner)

You may not qualify if:

  • Using sperm from a testicular source
  • Fewer than 10 oocytes retrieved
  • Fewer than 6 oocytes fertilized normally
  • Complete fertilization failure (no oocytes fertilize)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ronald O. Perelmand and Claudia Cohen Center for Reproductive Medicine

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

Aneuploidy

Interventions

Phosphatidylglycerols

Condition Hierarchy (Ancestors)

Chromosome AberrationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycerophospholipidsPhosphatidic AcidsGlycerophosphatesPhospholipidsMembrane LipidsLipids

Study Officials

  • Glenn Schattman

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2012

First Posted

April 10, 2012

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

December 1, 2014

Last Updated

June 11, 2015

Record last verified: 2015-06

Locations

US(1)