In Vitro Maturation of Human Eggs
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pregnancy
研究概览
简要总结
Because a large proportion of the embryo's quality is dependent upon the egg, this investigation focuses on treatment of the oocyte during in vitro maturation (IVM). In typical IVF cycles, the egg is recovered when it is mature and ready to be fertilized. However, at this point the oocyte's quality has been set, and cannot be altered. Therefore, to have an impact on oocyte quality the use of in IVM is critical. Development of a successful IVM protocol for clinical use would not only provide an option for women of advanced maternal age, it would also reduce the cost of IVF due to fewer exogenous gonadotropins used for stimulation, and significantly lessen the risk of ovarian hyper-stimulation.
The objective of this research study is to evaluate a newly developed oocyte maturation media system for human clinical use in assisted reproductive technology (ART).
详细描述
The novel device (IVM media system), is designed to support nuclear maturation of immature oocytes recovered after minimal ovarian stimulation with no LH/hCG administration, and improve oocyte competence. This may result in development of a greater number of embryos to the blastocyst stage.
FSH is administered starting on cycle day 3 to stimulate follicle growth. When the leading follicle reaches 12-14 mm, egg retrieval will be scheduled. No hCG/LH trigger will be administered. Specially designed maturation media is used to collect and culture the immature eggs once recovered from the follicle. Once the eggs have matured in vitro, fertilization and embryo culture, vitrification and comprehensive chromosomal screening will be completed as per standard operating procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women who desire to conceive and come to CCRM for infertility treatment using IVF will be candidates for this study.
- •Women with PCOS
- •Patients can be of any race, culture, sexual orientation or ethnicity.
排除标准
- •Minors are excluded from participation in this study.
- •Women with a BMI greater than 40
- •Women whose health is such that becoming pregnant carries risk significantly greater than healthy women are excluded from this study, unless they use a gestational carrier under the direction of their physician.
研究组 & 干预措施
IVM
Immature oocytes recovered from each subject will be placed into IVM media for maturation.
干预措施: IVM media (Device)
IVM
Immature oocytes recovered from each subject will be placed into IVM media for maturation.
干预措施: Follicle Stimulating Hormone (FSH) (Drug)
结局指标
主要结局
Pregnancy
时间窗: 6 months after egg retrieval
The incidence of pregnancy following embryo transfer of IVM produced embryos.
次要结局
- Development of good quality blastocysts using the Gardner morphological blastocyst grading system(7 days after egg retrieval)
- Offspring Weight(1 year after egg retrieval)
- Offspring Gender(1 year after egg retrieval)
- Fertilization of eggs(2 days after egg retrieval)
- Euploid Embryos(1 month after egg retrieval)