A Prospective Study Comparing the Outcomes of Single Versus Group Culture in Preimplantation Genetic Testing Cycles
1 other identifier
interventional
236
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2017
CompletedFirst Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2019
CompletedDecember 10, 2018
December 1, 2018
1.3 years
March 7, 2018
December 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
high quality blastocyst formation rate
number of blastocysts with high quality divided by number of zygotes with normal fertilization
6 days after fertilization
Secondary Outcomes (2)
embryo euploid rate
about one month after blastocyst biopsy
embryo implantation rate
about three to six months after blastocyst biopsy
Study Arms (2)
Single embryo culture
OTHEREmbryo is cultured individually in 25 ul media
Group embryo culture
OTHER2-3 Embryos are group cultured in 50 ul media
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients treated by preimplantation genetic diagnostic / screening cycles
You may not qualify if:
- number of normal fertilization zygotes is less than 6
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reproductive and Genetic Hospital of Citic-xiangya
Changsha, Hunan, 410000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaojuan Wang, Doc
Reproductive and Genetic Hospital of Citic-xiangya
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2018
First Posted
March 14, 2018
Study Start
October 23, 2017
Primary Completion
January 23, 2019
Study Completion
September 23, 2019
Last Updated
December 10, 2018
Record last verified: 2018-12