Effect of Single vs. Group CAPA-IVM Culture of Human Cumulus-oocyte Complexes From Small Antral Follicles in a SIBLING Oocyte Study Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of good quality embryos
研究概览
简要总结
Oocyte in vitro maturation (IVM) is a minimal-stimulation ART with reduced hormone-related side effects and risks for the patients. However, the approach is not widely used because of an efficiency gap compared to conventional ART. In order to further optimize and adapt the CAPA-IVM system in the IVM clinic, this pilot study aims to check the feasibility of applying a single COC CAPA-IVM strategy versus the group COC culture CAPA-IVM
详细描述
Oocyte in vitro maturation (IVM) is a minimal-stimulation ART with reduced hormone-related side effects and risks for the patients. However, the approach is not widely used because of an efficiency gap compared to conventional ART.
Oocytes retrieved for IVM procedures derive from a heterogeneous pool with variable cellular and molecular characteristics that indicate its immature status. Thus, in vitro systems that permit and enhance acquisition and synchronization of meiotic competence (ability to resume meiosis in response to an ovulatory stimulus) and developmental competence (ability to be fertilized and support early embryo development) before the meiotic trigger are crucial for the optimization of human IVM systems.
A novel two-step IVM culture system (named CAPA-IVM) involving a pre-maturation culture with C-type natriuretic peptide (CNP) and a maturation step in presence of Amphiregulin (AREG), both more physiological compounds improving oocyte competence, have been introduced in previous clinical studies. So far these pilot studies proved to increase the rates of oocyte maturation, good quality embryos on day 3, good quality blastocyst, and as a result a higher embryo yield. CAPA-IVM blastocysts have shown similar rates of methylation and gene expression at gDMRs compared to COS embryos; and the expression of ma-jor epigenetic regulators was similar between both groups. Furthermore, an improvement in pregnancy rates strengthens the clinical relevance of the use of CAPA-IVM strategy.
In order to further optimize and adapt the CAPA-IVM system in the IVM clinic, this pilot study aims to check the feasibility of applying a single COC CAPA-IVM strategy versus the group COC culture CAPA-IVM. A single COC culture would permit to perform a non-invasive molecular analysis per matured oocyte, in order to identify quality genes ex-pressed in cumulus cells post-IVM (cumulus biomarkers), which could be subsequently used to identify the embryo(s) with highest potential of implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having polycystic ovarian morphology: at least 25 follicles (2-9 mm) throughout the whole ovary and/or increased ovarian volume (>10ml) (it is sufficient that 1 ovary fits these criteria)
- •No major uterine or ovarian abnormalities
- •Having at least 15 follicles on the OPU day
- •Patients consent to participate in the study
排除标准
- •High (>grade 2) grade endometriosis
- •Cases with extremely poor sperm (serve OAT: density <1 million, mobility <10% and sperm from testicular surgery)
结局指标
主要结局
Number of good quality embryos
时间窗: At least 3 days after intra-cytoplasmic sperm injection
Number of good quality Day 3 embryos obtained
次要结局
- Fertilization rate(16-18 hours after intra-cytoplasmic sperm injection)
- Cleavage rate(At least 3 days after intra-cytoplasmic sperm injection)
- Multiple pregnancy(5 weeks after embryo placement after the completion of the first transfer)
- Multiple delivery(At 24 weeks' gestation)
- Live birth(At 24 weeks of gestation)
- Positive pregnancy test(at 2 weeks after the embryo placement after the completion of the first transfer)
- Ongoing pregnancy(At 12 weeks' gestation)
- Maturation rate(Two days after oocytes pick-up)
- The relative expression ratio ( R ) of human cumulus cell genes(cumulus cells will be collected after at least 30 hours of maturation culture, storaged at -80oC until RNA purification)
- Clinical pregnancy(5 weeks after embryo placement after the completion of the first transfer)
- Implantation rate(3 weeks after embryo transferred after the completion of the first transfer)
- Miscarriage(at 24 weeks of gestation after the completion of the first transfer)
- Expansion rate(After at least 30 hours of maturation culture)