NCT02974517

Brief Summary

Nowadays, the rapid development of human assisted reproductive technology (ART) has provided many help for couples with fertility issues. Even take baby home rate has been increased dramatically in the past several decades; both clinicians and embryologists are still struggling to improve pregnancy rates. Among all the strategies that the embryologists have tried, much work has been done to find better embryo culture conditions and embryo quality evaluation system. Currently, most centers in the world, including ours, are still using conventional incubators and manual embryo scoring system. This traditional method has several limitations, such as unstable environment during culture, and embryo scores can be different judged by different embryologists. EmbryoScope® by Vitrolife is a newly developed time-lapse embryo culture and analysis system. It is user-friendly, and suited for routinely daily use. In addition, its KID Score system can help embryologist select high quality embryos quickly, which leads to an overall increase in pregnancy outcome in IVF/ICSI cycles. The aim of this prospective cohort study is to evaluate the use of EmbryoScope® in our center.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 23, 2016

Last Update Submit

November 23, 2016

Conditions

the Application of Time-lapes System in IVF/ICSI

Keywords

time-lapesIVF/ICSIpregnancy outcome

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus

    5 weeks after embryo transfer

Secondary Outcomes (3)

  • 2 pronucleus (2PN) fertilization rate

    48 hours after oocyte retrieved day

  • Blastocyst formation rate

    6 days after oocyte retrieved day

  • High quality embryo rate

    72 hours after oocyte retrieved day

Study Arms (3)

Time-lapse-Auto

All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system.

Device: EmbryoScope®

Time-lapse-Manual

All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist.

Device: EmbryoScope®

Conventional Group

All embryos are cultured in our daily used incubators; embryo scores are evaluated on day 3 by embryologist.

Interventions

EmbryoScope®DEVICE

The intervention is EmbryoScope® versus conventional incubators.

Time-lapse-AutoTime-lapse-Manual

Eligibility Criteria

Age22 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All embyros are from women undergoing IVF/ICSI in our center.

You may qualify if:

  • First IVF/ICSI cycle;
  • With normal ovarian reserve(FSH \< 10 mIU/mL; antral follicle count\>5);
  • Age under 38 years old;
  • With normal uterine;
  • Tubal factor infertility

You may not qualify if:

  • Pre-implantation genetic diagnosis cycles;
  • Oocyte donation or sperm donation cycles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Related Publications (2)

  • Wu YG, Lazzaroni-Tealdi E, Wang Q, Zhang L, Barad DH, Kushnir VA, Darmon SK, Albertini DF, Gleicher N. Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study. Reprod Biol Endocrinol. 2016 Aug 24;14(1):49. doi: 10.1186/s12958-016-0181-x.

    PMID: 27553622BACKGROUND

  • Lazzaroni-Tealdi E, Barad DH, Albertini DF, Yu Y, Kushnir VA, Russell H, Wu YG, Gleicher N. Oocyte Scoring Enhances Embryo-Scoring in Predicting Pregnancy Chances with IVF Where It Counts Most. PLoS One. 2015 Dec 2;10(12):e0143632. doi: 10.1371/journal.pone.0143632. eCollection 2015.

    PMID: 26630267BACKGROUND

MeSH Terms

Interventions

Fetoscopes

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical Equipment

Central Study Contacts

Haixia Jin, M.D.

CONTACT

86-13523488589jhxgl@126.com

Zhiqin Bu, M.D.

CONTACT

86-15981978863rmczzu@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Reproductive Medical Center, 1st Affilated Hospital, Zhengzhou University

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 28, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2018

Last Updated

November 28, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)