The Application of Time-lapse System in IVF/ICSI

Study Overview
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Brief Summary
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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
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All patients included into this study are divided into three groups: Time-lapse-Auto: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system. Time-lapse-Manual: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist. 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.

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

Conditions
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the Application of Time-lapes System in IVF/ICSI

Intervention / Treatment
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* Device: EmbryoScope®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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time-lapes, IVF/ICSI, pregnancy outcome