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

Study Overview
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Brief Summary
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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.

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

Conditions
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Embryo Culture

Intervention / Treatment
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* Other: embryo culture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients treated by preimplantation genetic diagnostic / screening cycles Exclusion Criteria: number of normal fertilization zygotes is less than 6

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single embryo culture<br>Embryo is cultured individually in 25 ul media | Other: embryo culture<br>* 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.<br>|
| Other: Group embryo culture<br>2-3 Embryos are group cultured in 50 ul media | Other: embryo culture<br>* 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.<br>|

What is the study measuring?
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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 |