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

NCT ID: NCT03464643

Last Updated: 2018-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2019-09-23

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.

Detailed Description

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Conditions

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Embryo Culture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single embryo culture

Embryo is cultured individually in 25 ul media

Group Type OTHER

embryo culture

Intervention Type OTHER

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.

Group embryo culture

2-3 Embryos are group cultured in 50 ul media

Group Type OTHER

embryo culture

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Reproductive & Genetic Hospital of CITIC-Xiangya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaojuan Wang, Doc

Role: PRINCIPAL_INVESTIGATOR

Reproductive and Genetic Hospital of Citic-xiangya

Locations

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Reproductive and Genetic Hospital of Citic-xiangya

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuoping Zhang, Doc

Role: CONTACT

Phone: +86-731-88395640

Email: [email protected]

Lu Tan, Mrs

Role: CONTACT

Phone: +86-731-82355100

Email: [email protected]

Facility Contacts

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Xiaojuan Wang, Doc

Role: primary

Other Identifiers

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KYXM-20180307

Identifier Type: -

Identifier Source: org_study_id