Co-culture and Advanced Maternal Age in PGS Program

NCT01314846 | Terminated

• 1 other identifier: MAD-MN-10-2011-03
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Factors

Outcome Measures

Primary Outcomes (1)

• implantation rate

  from February 2009 to December 2010

Study Arms (2)

Control Group

sequential culture system

Co-culture system

Eligibility Criteria

• Age: 40 Years - 47 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women over 39 years old undergoing a PGS cycle

You may qualify if:

• Advanced maternal age (\>39) undergoing PGS cycle

You may not qualify if:

• Other PGS indication
• Altered karyotype

Sponsors & Collaborators

• IVI Madrid: lead

Study Sites (1)

IVI Madrid

Madrid, Madrid, 28023, Spain

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 10, 2011
• First Posted: March 15, 2011
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 29, 2016

Record last verified: 2011-03

Locations

ES (1)