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The Application of Time-lapse System in IVF/ICSI

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ClinicalTrials.gov Identifier: NCT02974517
Recruitment Status : Unknown
Verified November 2016 by Yingpu Sun, The First Affiliated Hospital of Zhengzhou University.
Recruitment status was:  Recruiting
First Posted : November 28, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Yingpu Sun, The First Affiliated Hospital of Zhengzhou University

Study Description
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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.

Condition or disease Intervention/treatment
the Application of Time-lapes System in IVF/ICSI 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 Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Application of Time-lapse System in IVF/ICSI: Can it be Beneficial to Final Pregnancy Outcome?
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 5 weeks after embryo transfer ]
    5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus


Secondary Outcome Measures :
  1. 2 pronucleus (2PN) fertilization rate [ Time Frame: 48 hours after oocyte retrieved day ]
    Number of 2PN/Matured oocytes

  2. Blastocyst formation rate [ Time Frame: 6 days after oocyte retrieved day ]
    Number of Blastocysts/Number of day 3 embryos cultured to blastocyst

  3. High quality embryo rate [ Time Frame: 72 hours after oocyte retrieved day ]
    High quality embryos that deserve to be transferred or cryopreserved/ Clevaged embryos in total


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All embyros are from women undergoing IVF/ICSI in our center.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974517


Contacts
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Contact: Haixia Jin, M.D. 86-13523488589 jhxgl@126.com
Contact: Zhiqin Bu, M.D. 86-15981978863 rmczzu@126.com

Locations
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China, Henan
Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Haixia Jin, M.D    86-13523488589    jhxgl@126.com   
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University
More Information
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Publications:

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Responsible Party: Yingpu Sun, Director of Reproductive Medical Center, 1st Affilated Hospital, Zhengzhou University, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT02974517    
Other Study ID Numbers: RMCZZU Time-lapse
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yingpu Sun, The First Affiliated Hospital of Zhengzhou University:
time-lapes
IVF/ICSI
pregnancy outcome