jRCT1052220197招募中不适用
Analysis of Preimplantation Genetic Testing for aneuploidy/structural rearrangement (PGT-A/SR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 383
- 主要终点
- ongoing pregnancy rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Screening
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 42age old under（—）
- 性别
- Female
入选标准
- •Infertile couples undergoing embryo transfer for which IVF or ICSI can be performed as an insured procedure, who wish to undergo PGT-A, and who meet the following selection criteria (1) to (3) and do not meet the exclusion criteria.
- •(1) Patients with a history of repeated IVF or ICSI/embryo transfer (ART) failures (repeated ART failures)
- •Selection Criteria
- •(1) Patients with a history of repeated IVF or ICSI/EMT failures.
- •(2) Able to obtain written consent to participate in the clinical research with his/her partner.
- •(3) If the research subject and his/her partner are both at least 18 years of age.
- •Persons with a history of repeated miscarriages (habitual miscarriage (including repeated miscarriages))
- •Selection Criteria
- •(1) Subjects with a history of repeated miscarriages and stillbirths
- •(2) Persons who are able to obtain written consent for participation in clinical research together with their partners.
- •Both the research subject and his/her partner are at least 18 years of age.
- •Chromosomal structural abnormalities (e.g., balanced chromosome translocations) in either the research subject or his/her partner are confirmed (chromosomal structural abnormalities).
- •Selection criteria
- •(1) Chromosome structural abnormalities (t(11;22)(q23;q11) for balanced reciprocal translocations, rob(13;14) for Robertsonian translocations, etc.) are confirmed in the research subject or his/her partner.
- •(2) Persons who are able to obtain written consent to participate in clinical research together with their partners.
- •Both the research subject and his/her partner are over 18 years old.
排除标准
- •Inappropriate ART patients with severe complications such as severe heart failure or other complications that are considered to have a significant potential to cause significant damage to maternal health during pregnancy and delivery
- •Patients who have undergone PGT-A/SR at least once in this study
- •Persons who have underwent embryotransfer in which has been performed PGT-A/SR in this study at least once
- •Other persons deemed inappropriate by the principal investigator or a physician who is a research participant.
结局指标
主要结局
ongoing pregnancy rate
时间窗: 12 gestational weeks to 13 gestational weeks
The ongoing pregnancy rate at 12 gestational weeks to 13 gestational weeks in the study population underwent embryo transfer.
次要结局
- Early miscarriage rate(from 12 gestational weeks to 13 gestational weeks)
- Pregnancy loss rate per implantation
- Implantation rate
- Clinical pregnancy rate per implantation
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