A Prospective Study of a Mosaic Embryo Transfer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Live birth rate
研究概览
简要总结
This research is a prospective study in which the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal cells) that has been screened for preimplantation genetic testing (PGT).
详细描述
This research is a prospective study with the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal cells) that has been screened for preimplantation genetic testing (PGT). PGT involves the biopsy and testing of a handful (3-6) of trophectoderm (pre-placental cells) from the embryo. Embryos that are screened as mosaic via PGT, as a standard, are not offered for transfer for pregnancy attempt. Publications have shown that mosaic embryos and mosaic fetuses can result in healthy live births (Wallerstein et al, 2015; Victor et al, 2019). Ongoing clinical outcomes are important to further understand the association between an embryonic mosaic biopsy of pre-placental cells and subsequent fetal chromosomal constitution. Implantation rates and live birth rates will be evaluated to help understand if mosaic embryos should routinely be offered for transfer to patients attempting pregnancy.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age 18-45 Infertile women who have completed an IVF cycle with PGT at the Colorado Center for Reproductive Medicine (CCRM) that have a mosaic embryo
- •Patients can be of any race, culture, sexual orientation or ethnicity
- •Patients that are willing to transfer a single embryo
排除标准
- •Patients that do not meet the clinical requirements for an embryo transfer per clinic standards.
- •Patients that desire more than a single embryo transfer.
- •Patients that are using a gestational carrier.
- •Embryonic mosaic PGT results that include chromosome errors 13, 18, 21
- •Patients that did not complete their IVF with PGT cycle at the Colorado Center for Reproductive Medicine.
结局指标
主要结局
Live birth rate
时间窗: 9-12 months post embryo transfer
Live birth rate will be evaluated
Evaluation of Implantation rate
时间窗: 3-4 weeks after embryo transfer
Ultrasound will be performed 2-3 weeks after initial positive pregnancy test to confirm viable pregnancy as evidenced by gestational sac in the uterus with a fetal heat rate
次要结局
- Pregnancy complications(9-12 months post embryo transfer)
- Stillbirth rates associated with Mosaic Embryo Transfer(9-12 months post embryo transfer)
- Miscarriage Rates(5-12 months post embryo transfer)
- Prenatal testing(9-12 months post embryo transfer)
- Products of conception from miscarriage(2-9 months post embryo transfer)
- Neonatal Outcomes(12-15 months after birth of baby)
研究者
Mandy Katz-Jaffe
Scientific and Genetics Director
Colorado Center for Reproductive Medicine