Prospective, Multi-center, Randomized, Controlled, Open Non-inferiority Trial Comparing a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 6
- 主要终点
- post-thawing survival rate
研究概览
简要总结
The GAVI® closed vitrification system is a CE labelled device licensed for use in human IVF. It has been developed to standardize the process of vitrification and to increase the safety of the procedure. It has been demonstrated that the novel semiautomated, closed vitrification system providing standardized equilibration prior to cryopreservation can produce similar results in terms of recovery rate and Embryo development up to the blastocyst stage as compared to the commonly used Manual Cryotop® open vitrifcation system when applied in a mouse model.
Furthermore, its application has resulted in first pregnancies after transfer of vitrifiedwarmed biopsied human blastocyts. Due to limitations of the preliminary studies (application in mouse model; absence of a larger clinical Trial assessing pregnancy and live birth rates in human model etc.) it is of paramount importance to compare the GAVI® vitrification method to the routinely used Cryotop® method in a human IVF setting employing randomization and a-priori sample size definitions.
The primary objective of this study is to demonstrate non-inferiority of vitrification using the semi-automated GAVI® closed system over the so-far routinely used manual Cryotop® open system in terms of post-thawing survival rate of 2PN oocytes.
The secondary objective of this trial is to study differences in embryo development, clinical pregnancy rate, ongoing pregnancy rate and live birth rate.
Furthermore, differences in procedure duration and convenience will be evaluated.
详细描述
One hundred and eighty (n=180) patients presenting more than 2 surplus 2 PNoocytes for vitrification or patients having all available 2PN oocytes electively vitrified will be randomly allocated (1:1) on day of fertilization check (day 1 after ovum pickup) to either procedure. In the study group, 2PN oocytes will be cryopreserved utilizing the semi-automated GAVI® open vitrification/warming technique.
In the control group, 2PN oocytes will be cryopreserved utilizing the manual Cryotop® open vitrification/warming technique.
The participation in this study will be limited to one cycle per patient. The study population consists of infertile couples undergoing IVF or ICSI treatment.
The study duration will be minimally 6 months per subject, e.g. the main study on the Primary outcome 2PN survival will be closed 6 months after randomization of the last patient.
Data from pregnancy and live birth outcome will be reported in addenda to the main clinical study report, as appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •IVF or ICSI treatment
- •2 or more surplus 2 PN oocytes OR elective cryopreservation of all 2 PN oocytes on day of fertilization check
- •willingness to participate (signed ICF)
排除标准
- •history of low response to controlled ovarian hyper stimulation in previous IVF or ICSI treatments (ESHRE Bologna criteria; Ferranetti et al., Hum Reprod 2011)
- •uterine pathology evident on transvaginal sonography, hysterosalpingography, hysteroscopy or laparoscopy
- •participation in a PGS or PGD program
- •previous participation in this study
结局指标
主要结局
post-thawing survival rate
时间窗: 2 hours
confirmation of survival by presence of intact oolemma and regular cytoplasm 2 hours post warming procedure and by observation of embryonic cleavage on
次要结局
- Clinical pregnancy rate(6 weeks)
- Number of top quality embryos on day 2(2 days)
- Number of top quality embryos on day 3(3 days)
- Ongoing pregnancy rate(12 weeks)
- Live birth rate(44 weeks)
- Number of top quality embryos on day 5(5 days)
- Number of top quality embryos on day 6(6 days)
研究者
Prof. Dr. med. M.Sc. Georg Griesinger
Prof. Dr. med. M.Sc.
University of Luebeck