The Application of Time-lapse System in IVF/ICSI

• Conditions: the Application of Time-lapes System in IVF/ICSI
• Interventions: Device: EmbryoScope®

• Registration Number: NCT02974517
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Last Update Submitted: 2016-11-23
• Study First Posted: 2016-11-28
• Last Update Posted: 2016-11-28
• Primary Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Time-lapse-Manual	EmbryoScope®	All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist.
Time-lapse-Auto	EmbryoScope®	All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	5 weeks after embryo transfer	5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus

Secondary Outcome Measures

Name	Time	Method
2 pronucleus (2PN) fertilization rate	48 hours after oocyte retrieved day	Number of 2PN/Matured oocytes
Blastocyst formation rate	6 days after oocyte retrieved day	Number of Blastocysts/Number of day 3 embryos cultured to blastocyst
High quality embryo rate	72 hours after oocyte retrieved day	High quality embryos that deserve to be transferred or cryopreserved/ Clevaged embryos in total

Trial Locations

Locations (1)

Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China