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Clinical Trials/NCT02974517
NCT02974517
Unknown
Not Applicable

The Application of Time-lapse System in IVF/ICSI: Can it be Beneficial to Final Pregnancy Outcome?

The First Affiliated Hospital of Zhengzhou University1 site in 1 country300 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
the Application of Time-lapes System in IVF/ICSI
Sponsor
The First Affiliated Hospital of Zhengzhou University
Enrollment
300
Locations
1
Primary Endpoint
Clinical pregnancy rate
Last Updated
9 years ago

Overview

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.

Detailed Description

All patients included into this study are divided into three groups: 1. Time-lapse-Auto: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system. 2. Time-lapse-Manual: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist. 3. Conventional Group: All embryos are cultured in our daily used incubators; embryo scores are evaluated on day 3 by embryologist. The aim is to compare IVF/ICSI outcomes, such as pregnancy outcome, fertilization rate, cleavage rate, high quality embryo rate, blastocyst formation rate, among these three groups.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
November 2018
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
The First Affiliated Hospital of Zhengzhou University
Responsible Party
Principal Investigator
Principal Investigator

Yingpu Sun

Director of Reproductive Medical Center, 1st Affilated Hospital, Zhengzhou University

The First Affiliated Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Clinical pregnancy rate

Time Frame: 5 weeks after embryo transfer

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

Secondary Outcomes

  • 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 Sites (1)

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