The Application of Time-lapse System in IVF/ICSI

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

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.

Study Overview

• Status: Unknown
• Conditions: the Application of Time-lapes System in IVF/ICSI
• Intervention / Treatment: Device: EmbryoScope®

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • Reproductive Medical Center, 1st Affiliated hospital of Zhengzhou University
      • Contact: Haixia Jin, M.D; Phone Number: 86-13523488589; Email: jhxgl@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Time-lapse-Auto; All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system.	Device: EmbryoScope®; The intervention is EmbryoScope® versus conventional incubators.
Time-lapse-Manual; All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist.	Device: EmbryoScope®; The intervention is EmbryoScope® versus conventional incubators.
Conventional Group; All embryos are cultured in our daily used incubators; embryo scores are evaluated on day 3 by embryologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus	5 weeks after embryo transfer

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Zhengzhou University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: November 23, 2016
• First Posted (Estimate): November 28, 2016

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: pregnancy outcome; time-lapes; IVF/ICSI
• Other Study ID Numbers: RMCZZU Time-lapse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No