Co-culture and Advanced Maternal Age in PGS Program (CC-PGS)

February 26, 2016 updated by: Fernando Bronet, IVI Madrid

Co-culture Versus Sequential Culture System in Advanced Maternal Age.

Fertilization and embryo development in vivo occurs in appropriate conditions in the mammalian reproductive tract. However in assisted reproductive technology (ART) embryos and oocytes are exposed to certain factors such as temperature, O2 pressure and pH fluctuations that may affect embryo development and viability in vitro. In Preimplantation Genetic Screening program (PGS) the investigators need to culture the embryos until day 5 so the requirement of culture techniques must be optimal to produce acceptable blastocyst rates. As it has been shown before, embryo culture conditions have the potential to impact biopsied embryos and hence PGS success rates.

Nowadays the coculture system with endometrial cells could be an alternative option to improve the blastocyst rates since some publications have indicated that endometrial cells may provide trace elements and growth factors that are not present in defined culture media and reproduce physiologic conditions. Although the role of coculture in vitro fertilization (IVF) has been controversial, a recent meta-analysis has established the potential benefits of coculture system.

The aim of this study was to compare embryologic and clinical outcomes in terms of blastocyst, implantation and pregnancy rates to evaluate endometrial epithelial cell (EEC) coculture versus sequential culture system in advanced maternal age ( ≥39 years) in the PGS program.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

346

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28023
        • IVI Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women over 39 years old undergoing a PGS cycle

Description

Inclusion Criteria:

  • Advanced maternal age (>39) undergoing PGS cycle

Exclusion Criteria:

  • Other PGS indication
  • Altered karyotype

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control Group
sequential culture system
Co-culture system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
implantation rate
Time Frame: from February 2009 to December 2010
from February 2009 to December 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimate)

March 15, 2011

Study Record Updates

Last Update Posted (Estimate)

February 29, 2016

Last Update Submitted That Met QC Criteria

February 26, 2016

Last Verified

March 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • MAD-MN-10-2011-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age Factors

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe