In Vitro Maturation of Human Eggs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Oocyte maturation
研究概览
简要总结
CCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Participants that qualify for the study will receive a free cycle of IVM treatment at CCRM Fertility and including a new patient consultation, fertility testing, preimplantation genetic testing for aneuploidies (PGT-A), anesthesia and some medication
详细描述
Patients will undergo a complete IVF workup to qualify for study. Once passing their baseline appointment patients will undergo a three day low dose stimulation followed by egg retrieval 18-22 hours post last medication dosage. Immature oocytes will be retrieved from the ovaries via ultrasound guided TV aspiration and matured overnight in the laboratory. Mature oocytes will be fertilized via ICSI the following day and cultured to the blastocyst stage. Biopsy of the first 14 blastocysts are included with this package, patients have the option biopsy additional embryos if available. Biopsies will be sent for PGTA testing. This study also includes preparation for and the first frozen embryo transfer. Some FET medication is included as well as testing through the first pregnancy test.
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
- — 至 38 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women diagnosed with PCOS or polycystic ovaries, or infertile women with good ovarian reserve
- •Antral follicle count (AFC) greater than 24
- •AMH greater than 3.5 ng/ml
- •Body Mass Index less than 35
- •Accept to have embryos biopsied for PGT
- •Intend to perform embryo transfer within 4 months after completing the IVM cycle
- •Paternal (or donor) age <45, ejaculated sperm collection only (partner frozen and donor sperm acceptable), sperm morphology (strict criteria) >1%, motility > 20% and sperm count > 10 million per ml (so samples can be prepared through standard procedure)
排除标准
- •More than 2 failed IVF cycles
结局指标
主要结局
Oocyte maturation
时间窗: 27 hours
Maturation rate of retrieved oocytes
Embryo fertilization and development
时间窗: 7 days
Number of embryos that fertilize and develop after ICSI. Blastocysts will be biopsied and frozen on days 5, 6, and 7 of development
Pregnancy
时间窗: 6 months
Pregnancy following embryo transfer. HCG levels and ultrasound confirming IUP and heartrate.
次要结局
- Live Birth(12 months)