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

This study has been terminated.
(difficulty to include patients)
Sponsor:
Information provided by (Responsible Party):
Fernando Bronet, IVI Madrid
ClinicalTrials.gov Identifier:
NCT01314846
First received: March 10, 2011
Last updated: February 26, 2016
Last verified: March 2011
  Purpose

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
Age Factors

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Co-culture Versus Sequential Culture System in Advanced Maternal Age.

Further study details as provided by IVI Madrid:

Primary Outcome Measures:
  • implantation rate [ Time Frame: from February 2009 to December 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 346
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control Group
sequential culture system
Co-culture system

  Eligibility

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

Inclusion Criteria:

  • Advanced maternal age (>39) undergoing PGS cycle

Exclusion Criteria:

  • Other PGS indication
  • Altered karyotype
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01314846

Locations
Spain
IVI Madrid
Madrid, Spain, 28023
Sponsors and Collaborators
IVI Madrid
  More Information

Responsible Party: Fernando Bronet, PhD, IVI Madrid
ClinicalTrials.gov Identifier: NCT01314846     History of Changes
Other Study ID Numbers: MAD-MN-10-2011-03 
Study First Received: March 10, 2011
Last Updated: February 26, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica

ClinicalTrials.gov processed this record on September 28, 2016