Co-culture and Advanced Maternal Age in PGS Program

NCT ID: NCT01314846

Last Updated: 2016-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

346 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age Factors

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Control Group

sequential culture system

No interventions assigned to this group

Co-culture system

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Other PGS indication
* Altered karyotype
Minimum Eligible Age

40 Years

Maximum Eligible Age

47 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IVI Madrid

OTHER

Sponsor Role lead

Responsible Party

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Fernando Bronet

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IVI Madrid

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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MAD-MN-10-2011-03

Identifier Type: -

Identifier Source: org_study_id

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