Co-culture and Advanced Maternal Age in PGS Program

Age Factors Clinical Trial

— CC-PGS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01314846
• Other study ID #: MAD-MN-10-2011-03
• Status: Terminated
• Phase: N/A
• First received: March 10, 2011
• Last updated: February 26, 2016
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: IVI Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 346
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 47 Years

Eligibility

Inclusion Criteria:

• Advanced maternal age (>39) undergoing PGS cycle

Exclusion Criteria:

• Other PGS indication

• Altered karyotype

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Age Factors

Locations

Country	Name	City	State
Spain	IVI Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	implantation rate		from February 2009 to December 2010	Yes