CClinicalTrials.gg
Status unknownNCT04011319Updated Jul 8, 2019

Group Culture May Affect Embryo Quality in Assisted Reproduction Technology

An interventional study of group culture in Embryo Quality, sponsored by Tang-Du Hospital. Status unknown at 1 site in China. Open to female participants aged 22 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-08.

Sponsored by Tang-Du Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Randomized
Ages
22 Years to 40 Years
Sex
Female
01

Study 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.

Read the detailed description

Providing optimal culture conditions for the embryos in ART is crucial, due to its high impact on embryo development and thus on the pregnancy outcome. Several strategies have been proposed in order to improve embryo culture conditions and clinical pregnancy rates. Currently, the establishment of autocrine and paracrine communications and embryo-to-embryo interactions should contribute to the detoxification of the culture medium, facilitating embryo development and improving the implantation rate. Many studies have provided evidence related to the impact of group culture condition on the success of the embryonic development in animals. But the advantage of group culture to improve the embryonic development and pregnancy outcomes of ART in human remains elusive. Therefore, the investigator aim to discuss the effectiveness of group culture in ART.

In this study, zygotes derived from sibling oocytes were randomized 1:1 to either the microwell group culture (experiment group) or conventional droplet culture (control group). In experiment group, 4 zygotes cultured in a new special microwell (120 μl droplet were divided into 4 areas) with a corral dish (EMBC-010, LifeGlobal), embryos can communicate with each other in the same culture environment. In control group, single embryo individually cultured in a droplet (60 μl). Embryos were cultured in specific desktop three-gas incubators (COOK) of 37°C, 6% CO2 (carbon dioxide) , 5% O2 and 89% N2, and scored according to the criteria described in the ESHRE-ALPHA consensus. Consequently, exploitable embryos rate, good embryo quality, blastocyst formation rate were recorded. Other relevant parameters such as clinical pregnancy, live-birth or miscarriage were also recorded to evaluate the outcomes. Proper culture conditions can result in superior embryo viability, this research intends to discuss whether group culture can improve the embryo quality and clinical outcomes in ART.

02

Conditions studied

  • Embryo Quality

Keywords

  • Group culture
  • Embryo quality
  • Implantation rate
  • Clinical pregnancy
03

In context

Lead sponsor

Tang-Du Hospital is the lead sponsor of 164 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Number of mature oocytes less than 6.
  • The number of normal fertilized zygotes less than 4.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
2,000 participants (estimated)

Study arms

  • No intervention
    convention culture

    Each droplet separate culturing an individual embryo.

  • Experimental
    group culture

    Embryos were cultured in the same droplet.

    Behavioral: group culture

Interventions

  • Behavioralgroup culture

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

06

What researchers measure

Primary outcomes

  1. Efficacy of group culture on embryo potential

    Embryo potential was evaluated by the clinical pregnancy rate

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Tangdu Hospital
    Xi'an, Shaanxi 710038, China
    • Ming Wang · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04011319
Lead sponsor
Tang-Du Hospital
Responsible party
Sponsor
First posted
Jul 8, 2019
Start date
Apr 1, 2019
Primary completion
Mar 2020 (estimated)
Completion
Mar 2020 (estimated)
Last update
Jul 8, 2019

Study contacts

Ming Wang
Contact
wangmingbio@snnu.edu.cn
8613259809290
Bo Li
study director · Tang-Du Hospital

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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