NCT03118141

Cumulative Live Birth Rate With eSET After Preimplantation Genetic Screening Versus Conventional In-vitro Fertilization

Cumulative Live Birth Rate With eSET After In-vitro Fertilization With Preim-plantation Genetic Screening by Next Generation Sequencing Versus Conventional In-vitro Fertilization: A Pragmatic Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,215 (estimated)
• Sponsor: Chen Zi-Jiang · Academic / Other
• Sex: Female
• Age: 20 Years – 37 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized clinical trial is to compare the efficacy and safety with transfer of embryos selected by next generation sequencing (NGS) versus conventional morphological criteria. Subjects with 3 or more blastocysts on day 5 of embryo culture will be randomized to the PGS or IVF group. A Freeze-all strategy and a single frozen blastocyst transfer will be performed in both PGS and IVF groups. The primary outcome is the cumulative live birth after transfers of up to 3 single blastocycsts in both groups.

Detailed description

This is a multicenter, randomized clinical trial comparing the efficacy and safety with transfer of embryos selected by next generation sequence (NGS) and morphologic criteria versus by morphological criteria alone. Subjects who obtain 3 or more good-quality blastocysts will be randomized to PGS or IVF group. All embryos will be frozen and a single thawed blastocyst will be transferred in both PGS and IVF group. Subjects in the PGS group will have 3 blastocysts sequenced and euploid embryos will be subsequently transferred. Subjects in the IVF group will have blastocysts selected by morphology assessment. The cumulative live birth rate will be counted after transfers of all euploid embryo in the PGS group and 3 blastocysts in the IVF group within 1 year after randomization.

Conditions

• Infertility

Interventions

Type	Name	Description
PROCEDURE	blastocyst morphologic score	Blastocysts will be scored by Gardner morphologic criteria.
PROCEDURE	blastocyst biopsy and sequencing	Three blastocysts will be biopsied on trophectoderm, sequenced with next-generation sequencing (NGS). Euploidy will transferred one by one according to morphologic score.
PROCEDURE	freeze-all and single thawed blastocyst transfer	All blastocysts will be vitrified in fresh cycle. Single blastocyst will be thawed and transferred.

Timeline

• Start date: 2017-07-09
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2017-04-18
• Last updated: 2019-09-20

Locations

1 site across 1 country: China