Clinical trial NCT02974517: The Application of Time-lapse System in IVF/ICSI
Official title: The Application of Time-lapse System in IVF/ICSI: Can it be Beneficial to Final Pregnancy Outcome?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: the Application of Time-lapes System in IVF/ICSI
Keywords: time-lapes
IVF/ICSI
pregnancy outcome
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 300
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All embyros are from women undergoing IVF/ICSI in our center.

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.

Eligibility 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.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 5 weeks after embryo transfer
Secondary outcomes:
measure: 2 pronucleus (2PN) fertilization rate
timeFrame: 48 hours after oocyte retrieved day
measure: Blastocyst formation rate
timeFrame: 6 days after oocyte retrieved day
measure: High quality embryo rate
timeFrame: 72 hours after oocyte retrieved day
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References:
citation: 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.
citation: 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.