Effect of the Use of Oocyte-specific or Universal Vitrification and Warming Media on Pregnancy Rates in the Context of Oocyte Donation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Impact of vitrification and warming media on clinical pregnancy rate per fresh embryo transfer
研究概览
简要总结
Vitrification has become the gold standard for oocyte and embryo cryopreservation. Several commercial kits are available on the market, some are designed for specific developmental stages (e.g. oocytes, zygotes, cleavage-stage embryos or blastocysts) and others are suitable for several stages, therefore termed "universal". Oocytes, cleavage-stage embryos and blastocysts display different levels of resistance to cryopreservation, due to stage-specific properties. While the composition and the exposition protocol of stage specific media are optimized for specific developmental stages, "universal" media display a single composition, therefore exposition protocols should be adapted to each specific developmental stage to ensure optimal survival rates.
The main objective of this study is to determine whether the shift from "oocyte specific" vitrification and warming media to "universal" media has an impact oocyte survival, embryological and clinical outcomes.
详细描述
A retrospective, monocentric study comparing the clinical and embryological outcomes of 111 oocyte recipient cycles with ICSI from March 2016 to July 2020. Baseline characteristics (donor age and BMI, ovarian stimulation protocol, number of collected oocytes) of the 81 related donations were also analysed.
Two generations of vitrification and warming media were used during this period:
- "Oocyte-specific": RapidVit™ Oocyte and RapidWarm™ Oocyte, Vitrolife
- "Universal": RapidVit™ Omni and RapidWarm™ Omni, Vitrolife Patients were divided in 3 groups according to the combination of the vitrification medium and the warming medium : "specific/specific" (S/S), "specific/universal" (S/U) and "universal/universal" (U/U)..
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient couples undergoing an oocyte donation ICSI cycle from March 2016 to July 2020 for whom the allocated oocytes were vitrified in our center between July 2015 and January 2020
排除标准
- •Recipient couples undergoing an oocyte donation ICSI cycle from March 2016 to July 2020 for whom the allocated oocytes were vitrified prior to July 2015 or after January 2020.
研究组 & 干预措施
S/S - Vitrified and warmed with Oocyte-specific medium
41 oocyte recipient ICSI cycles for which the initial oocyte vitrification procedure was performed with "oocyte- specific" medium RapidVit™ Oocyte (Vitrolife) and the warming procedure was performed with "oocyte-specific" medium RapidWarm™ Oocyte (Vitrolife)
干预措施: Vitrification and warming media for oocyte vitrification (Other)
S/U - Vitrified with Oocyte-specific medium, Warmed with universal medium
39 oocyte recipient ICSI cycles for which the initial oocyte vitrification procedure was performed with "oocyte- specific" medium RapidVit™ Oocyte (Vitrolife) and the warming procedure was performed with "universal" medium RapidWarm™ Omni (Vitrolife)
干预措施: Vitrification and warming media for oocyte vitrification (Other)
U/U - Vitrified and warmed with universal medium
31 oocyte recipient ICSI cycles for which the initial oocyte vitrification procedure was performed with "universal" medium RapidVit™ Oocyte (Vitrolife) and the warming procedure was performed with "universal" medium RapidWarm™ Omni (Vitrolife)
干预措施: Vitrification and warming media for oocyte vitrification (Other)
结局指标
主要结局
Impact of vitrification and warming media on clinical pregnancy rate per fresh embryo transfer
时间窗: UltraSound at 1 month after embryo transfer
number of clinical pregnancies (one or more gestational sacs visualized in ultrasonography) expressed per 100 embryo transfers
次要结局
- Impact of vitrification and warming media on live birth rate per embryo transfer(42 weeks)
- Impact of vitrification and warming media on top-quality embryo percentage(43-45 hours)
- Impact of vitrification and warming media on oocyte survival rate(two hours after warming procedure)
- Impact of vitrification and warming media on fertilization rate(16-18 hours)
- Impact of vitrification and warming media on day-2 embryo percentage(43-45 hours)
- Impact of vitrification and warming media on blastulation rate(114-118 hours)
- Impact of vitrification and warming media on implantation rate(114-118 hours)
- Impact of vitrification and warming media on miscarriage rate per embryo transfer(up to 42 weeks)
- Impact of vitrification and warming media on good quality blastocyst rate(114-118 hours)