Comparison of Frozen-thawed Embryo Transfers and Fresh Embryo Transfers With Whole Chromosome Analysis Using Next Generation Sequencing
试验速览
- 阶段
- 2 期
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Implantation rate
研究概览
简要总结
The investigators propose to perform a clinical randomized trial to evaluate the effect of a frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation rates; with the added benefit of a blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS).
详细描述
- Fresh group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5, analyzed by NGS, and will have one or two euploid embryo transferred on day 6, in the am. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*). Any morulas developing to hatching blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.
- Frozen group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5 or day 6, embryos will then be vitrified, analyzed by NGS, and will have one or two euploid embryo(s) thawed and transferred on a FET cycle, before noon. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*).
(*) Hatching blastocysts as described by Gardner and Schoolcraft (1999):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(pre-stimulation):
- •Age up to 42 years
排除标准
- •(pre-stimulation):
- •MESA and TESE patients
- •At least one partner carrier of a chromosomal abnormality
- •Egg donor cycle (sperm donor is acceptable)
- •Gender selection cycles
- •Thaw cycles
- •Any patient who cannot have a fresh embryo transfer
- •FSH above 12 or AMH less than 1
研究组 & 干预措施
Frozen Embryo Transfer with PGD
All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5 or day 6, embryos will then be vitrified, analyzed by NGS, and will have one or two euploid embryo(s) thawed and transferred on a FET cycle, before noon. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*).
干预措施: PGD (Other)
Fresh Embryo Transfer with PGD
All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5, analyzed by NGS, and will have one or two euploid embryo transferred on day 6, in the am. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*). Any morulas developing to hatching blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.
干预措施: PGD (Other)
结局指标
主要结局
Implantation rate
时间窗: 8 weeks after replacement
determining whether a frozen or a fresh embryo transfer will improve implantation rate.
次要结局
- Correlation of Mitochondrial DNA and implantation(When a fetal heartbeat is detected (8 weeks after implantation))