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

Embryo Culture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03464643
• Other study ID #: KYXM-20180307
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: September 23, 2019

Study information

• Verified date: December 2018
• Source: Reproductive & Genetic Hospital of CITIC-Xiangya
• Contact: Shuoping Zhang, Doc
• Phone: +86-731-88395640
• Email: baibaipang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: September 23, 2019
• Est. primary completion date: January 23, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• patients treated by preimplantation genetic diagnostic / screening cycles

Exclusion Criteria:

• number of normal fertilization zygotes is less than 6

Related Conditions & MeSH terms

• Embryo Culture

Intervention

Other:
• embryo culture
Single embryo culture means only one embryo is cultured in one drop, and the group culture refers to culture of 2-5 embryos in one drop. The main advantage of group culture may be secreting some paracrine cytokines by embryos and benefit each other; and the possible disadvantage of group culture is that embryo secreting of some harmful substances which accumulated to a certain extent will damage the developmental potential of embryos. The advantages and disadvantages of single embryo culture are contrary to group culture.

Locations

Country	Name	City	State
China	Reproductive and Genetic Hospital of Citic-xiangya	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high quality blastocyst formation rate	number of blastocysts with high quality divided by number of zygotes with normal fertilization	6 days after fertilization
Secondary	embryo euploid rate	number of euploid blastocysts divided by all blastocysts detected	about one month after blastocyst biopsy
Secondary	embryo implantation rate	number of gestational sacs divided by number of embryo transferred	about three to six months after blastocyst biopsy