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

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

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.

Study Overview

• Status: Unknown
• Conditions: Embryo Culture
• Intervention / Treatment: Other: embryo culture

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuoping Zhang, Doc; Phone Number: +86-731-88395640; Email: baibaipang@hotmail.com
• Study Contact Backup: Name: Lu Tan, Mrs; Phone Number: +86-731-82355100; Email: 10931212@qq.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Reproductive and Genetic hospital of CITIC-xiangya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• patients treated by preimplantation genetic diagnostic / screening cycles

Exclusion Criteria:

• number of normal fertilization zygotes is less than 6

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Single embryo culture; Embryo is cultured individually in 25 ul media	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.
OTHER: Group embryo culture; 2-3 Embryos are group cultured in 50 ul media	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
high quality blastocyst formation rate	number of blastocysts with high quality divided by number of zygotes with normal fertilization	6 days after fertilization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
• Investigators: Principal Investigator: Xiaojuan Wang, Doc, Reproductive and Genetic hospital of CITIC-xiangya

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2017
• Primary Completion (ANTICIPATED): January 23, 2019
• Study Completion (ANTICIPATED): September 23, 2019

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (ACTUAL): March 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: KYXM-20180307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No