CClinicalTrials.gg
Status unknownNCT03464643Updated Dec 10, 2018

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

An interventional study of embryo culture in Embryo Culture, sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya. Status unknown at 1 site in China. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-12-10.

Sponsored by Reproductive & Genetic Hospital of CITIC-Xiangya · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Embryo Culture
03

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • patients treated by preimplantation genetic diagnostic / screening cycles

Exclusion criteria

Exclusion Criteria:

  • number of normal fertilization zygotes is less than 6
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
236 participants (estimated)

Study arms

  • Other
    Single embryo culture

    Embryo is cultured individually in 25 ul media

    Other: embryo culture

  • Other
    Group embryo culture

    2-3 Embryos are group cultured in 50 ul media

    Other: embryo culture

Interventions

  • Otherembryo 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.

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What researchers measure

Primary outcomes

  1. high quality blastocyst formation rate

    number of blastocysts with high quality divided by number of zygotes with normal fertilization

    Time frame: 6 days after fertilization

Secondary outcomes

  1. embryo euploid rate

    number of euploid blastocysts divided by all blastocysts detected

    Time frame: about one month after blastocyst biopsy

  2. embryo implantation rate

    number of gestational sacs divided by number of embryo transferred

    Time frame: about three to six months after blastocyst biopsy

06

Study locations

1 of 1 sites recruiting
  • Reproductive and Genetic Hospital of Citic-xiangya
    Changsha, Hunan 410000, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03464643
Lead sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
Responsible party
Sponsor
First posted
Mar 14, 2018
Start date
Oct 23, 2017
Primary completion
Jan 23, 2019 (estimated)
Completion
Sep 23, 2019 (estimated)
Last update
Dec 10, 2018

Study contacts

Shuoping Zhang, Doc
Contact
baibaipang@hotmail.com
+86-731-88395640
Lu Tan, Mrs
Contact
10931212@qq.com
+86-731-82355100
Xiaojuan Wang, Doc
principal investigator · Reproductive and Genetic Hospital of Citic-xiangya

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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