A Prospective Study Comparing the Outcomes of Single Versus Group Culture in Preimplantation Genetic Testing Cycles

Not Applicable

• Conditions: Embryo Culture
• Interventions: Other: embryo culture

• Registration Number: NCT03464643
• Lead Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

Brief Summary

The aim of this study is to analyze whether there is difference in the effect of single embryo culture and group culture in preimplantation genetic screening (PGS) cycle, and provide reference for the feasibility of the clinical application of medium-based noninvasive PGD. This prospective study prepares for more than 1,000 normal fertilized zygotes in each group over one year period. For the recruited patients, all normal fertilized zygotes were randomly allocated into two groups: cultured individually in 25 ul media or 2-3 embryos cultured together in 50 ul media. The blastocyst formation rates, aneuploid rates, clinical pregnancy rates, implantation rates and miscarriage rates will be compared between the two groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-23
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-10
• Primary Completion: 2019-01-23
• Study Completion: 2019-09-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 236

Inclusion Criteria

• patients treated by preimplantation genetic diagnostic / screening cycles

Exclusion Criteria

• number of normal fertilization zygotes is less than 6

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group embryo culture	embryo culture	2-3 Embryos are group cultured in 50 ul media
Single embryo culture	embryo culture	Embryo is cultured individually in 25 ul media

Primary Outcome Measures

Name	Time	Method
high quality blastocyst formation rate	6 days after fertilization	number of blastocysts with high quality divided by number of zygotes with normal fertilization

Secondary Outcome Measures

Name	Time	Method
embryo euploid rate	about one month after blastocyst biopsy	number of euploid blastocysts divided by all blastocysts detected
embryo implantation rate	about three to six months after blastocyst biopsy	number of gestational sacs divided by number of embryo transferred

Trial Locations

Locations (1)

Reproductive and Genetic Hospital of Citic-xiangya; 🇨🇳 Changsha, Hunan, China