NCT02353364

Blastocyst Euploidy Assessment and Conditioned embryO traNsfer

Prospective Randomised Control Trial of Blastocyst Euploidy Assessment and Conditioned Embryo Transfer for Infertility Patients of Advanced Maternal Age

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: Female
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to evaluate the effectiveness of pre-implantation genetic screening (PGS) for infertility patients of advanced maternal age undergoing assisted reproductive treatment. Half of the patients will have their embryos tested by PGS and 1 or 2 chromosomally normal embryos with the highest morphological grading transplanted back to the uterus. The other half of the participants will not have their embryos tested and 1 or 2 untested embryos with the highest morphological grading transplanted back to the uterus.

Detailed description

PGS is an assisted reproductive technology that screens patients embryos, discriminating between embryos with a normal set of chromosomes (euploid) and those with an abnormal set of chromosomes (aneuploid). In this study, we will apply a novel validated next generation sequencing technology called copy number variation sequencing (CNV-Seq) to comprehensively screen a trophectoderm biopsy sample from patient's embryos for chromosomal abnormalities that commonly arise in human embryos. The hypothesis is that PGS performed using CNV-Seq on embryos produced by patients with a poor prognosis for pregnancy (maternal age \> 35), followed by transfer of chromosomally normal euploid embryos, will result in significantly higher implantation, pregnancy and live birth rates and lower miscarriage rates compared to patients having no PGS.

Conditions

• Infertility

Interventions

Type	Name	Description
OTHER	PGS	Embryos screened by the validated NGS technology CNV-Seq

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-12-01
• Completion: 2016-10-01
• First posted: 2015-02-02
• Last updated: 2015-02-02

Locations

1 site across 1 country: China