Vitrification of In Vitro Matured Oocytes Following the CAPA-IVM Methodology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Oocyte survival rate
研究概览
简要总结
It has been reported that the potential of In Vitro matured oocytes might be affected by the vitrification process. In fact, the freezing and thawing procedures routinely used in IVF laboratories, have not yet been adapted to oocytes coming from early antral follicles (normally used for In Vitro Maturation).
This study aims to compare 2 existing protocols for the Vitrification of In Vitro matured oocytes.
详细描述
This is a single-center non-blinded observational study.
The proposed study will follow a sibling oocyte design in infertile patients. In Vitro Maturation will be performed by using the Capacitation-IVM (CAPA-IVM) methodology.
All cumulus-oocyte complexes (COC) recovered from the patient will be cultured in CAPA medium for 24 hours and then matured for 30 hours (IVM). A minimum of 10 metaphase II (MII) stage oocytes are expected from each CAPA-IVM procedure.
After CAPA-IVM culture, the mature oocytes (MII) will be randomly divided (50/50) into two groups to be subjected to the two vitrification protocols.
In a second step (next cycle), the oocytes from each group will be thawed and fertilized by Intracytoplasmic sperm injection (ICSI). The derived embryos will be cultured to the blastocyst stage (Day 5/6).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with Polycystic ovary morphology: At least 25 follicles (2-9 mm) throughout the ovary and/or increased ovarian volume (>10ml) (it is enough for 1 ovary to meet these criteria)
- •Patients with good ovarian reserve: High antral follicle count (AFC): ≥ 20 antral follicles in both ovaries or Anti-müllerian hormone (AMH) value ≥3.5 ng/ml
- •In both cases, without significant uterine or ovarian anomalies
排除标准
- •There are contraindications for the administration of gonadotropins, oral contraceptives and/or other drugs used in the framework of the present study.
- •Preimplantation Genetic Testing (PGT) Cycles
- •Oocyte donation cycles
- •Medical contraindication for pregnancy.
- •High grade endometriosis (> grade 2)
- •Cases with extremely poor sperm
结局指标
主要结局
Oocyte survival rate
时间窗: 6 months
The survival rate will be calculated by dividing the number of oocytes that survive freezing/thawing by the number of oocytes originally frozen. Survival rate will be evaluated per patient, per vitrification protocol.
次要结局
- Fertilization rate(6 months)
- Rate of Good quality blastocysts(6 months)
- Cleavage rate(6 months)
- Rate of Blastocyst formation(6 months)
- Live birth rate(15 months)
- Clinical pregnancy rate(15 months)
- Oocyte maturation rate(6 months)
研究者
Sergio Romero
Research Director
Centro de Fertilidad y Reproducción Asistida, Peru