NCT04011319

Brief Summary

One of the vital factors in achieving pregnancies in assisted reproductive technologies (ART) is maximizing embryo quality, which is significantly influenced by embryo culture conditions. A microwell culture system that facilitates group culture, improves embryonic development. The investigators use a new special culture dish to examine the effect of group culture on embryonic development in vitro. Zygotes derived from sibling oocytes were completely denuded from cumulus cells and spermatozoa, then randomly divided into conventional droplet culture or group culture. Embryos cultured in microwell system (group culture) were compared to conventional droplet culture (one zygote per drop). Relevant parameters are recorded to evaluate the validity of group culture in ART.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 31, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 8, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

March 31, 2019

Last Update Submit

July 3, 2019

Conditions

Embryo Quality

Keywords

Group cultureEmbryo qualityImplantation rateClinical pregnancy

Outcome Measures

Primary Outcomes (1)

  • Efficacy of group culture on embryo potential

    Embryo potential was evaluated by the clinical pregnancy rate

    1 year

Study Arms (2)

convention culture

NO INTERVENTION

Each droplet separate culturing an individual embryo.

group culture

EXPERIMENTAL

Embryos were cultured in the same droplet.

Behavioral: group culture

Interventions

group cultureBEHAVIORAL

Four embryos were cultured in the same droplet by a special dish.

group culture

Eligibility Criteria

Age22 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing IVF/ICSI cycle.
  • Number of oocytes≥ 8.

You may not qualify if:

  • Number of mature oocytes less than 6.
  • The number of normal fertilized zygotes less than 4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Study Officials

  • Bo Li

    Tang-Du Hospital

    STUDY DIRECTOR

Central Study Contacts

Ming Wang

CONTACT

8613259809290wangmingbio@snnu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2019

First Posted

July 8, 2019

Study Start

April 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

July 8, 2019

Record last verified: 2019-06

Locations

CN(1)