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The Application of Time-lapse System in IVF/ICSI

NCT ID: NCT02974517

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

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:

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.

Conditions

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the Application of Time-lapes System in IVF/ICSI

Keywords

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time-lapes IVF/ICSI pregnancy outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Time-lapse-Auto

All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system.

EmbryoScope®

Intervention Type DEVICE

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.

EmbryoScope®

Intervention Type DEVICE

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.

No interventions assigned to this group

Interventions

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EmbryoScope®

The intervention is EmbryoScope® versus conventional incubators.

Intervention Type DEVICE

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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Yingpu Sun

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haixia Jin, M.D.

Role: CONTACT

Phone: 86-13523488589

Email: [email protected]

Zhiqin Bu, M.D.

Role: CONTACT

Phone: 86-15981978863

Email: [email protected]

Facility Contacts

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Haixia Jin, M.D

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 27553622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26630267 (View on PubMed)

Other Identifiers

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RMCZZU Time-lapse

Identifier Type: -

Identifier Source: org_study_id