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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01314846
Recruitment Status : Terminated (difficulty to include patients)
First Posted : March 15, 2011
Last Update Posted : February 29, 2016
Information provided by (Responsible Party):
Fernando Bronet, IVI Madrid

Brief Summary:

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.

Condition or disease
Age Factors

Study Type : Observational
Actual Enrollment : 346 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Co-culture Versus Sequential Culture System in Advanced Maternal Age.
Study Start Date : February 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : December 2010

Control Group
sequential culture system
Co-culture system

Primary Outcome Measures :
  1. implantation rate [ Time Frame: from February 2009 to December 2010 ]

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Ages Eligible for Study:   40 Years to 47 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women over 39 years old undergoing a PGS cycle

Inclusion Criteria:

  • Advanced maternal age (>39) undergoing PGS cycle

Exclusion Criteria:

  • Other PGS indication
  • Altered karyotype

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01314846

IVI Madrid
Madrid, Spain, 28023
Sponsors and Collaborators
IVI Madrid

Responsible Party: Fernando Bronet, PhD, IVI Madrid Identifier: NCT01314846     History of Changes
Other Study ID Numbers: MAD-MN-10-2011-03
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: March 2011