Ambispective Comparative Cohort Study to Assess the Differences in Development and Growth Patterns of Biopsied and Non-Biopsied ICSI Embryos and Natural Pregnancy Embryos[BNB-ICSI Study]
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Third primary endpoint
研究概览
简要总结
As Pre Implantation Genetic Screening (PGS) becomes now a replacement modality and trend gaining popularity among physicians and patients on claiming its ability to settle on the simplest genetically normal embryo, so it had been logical to review if taking cells from the embryo in its early development will or won't affect its growth as compared to the previous standard technique of ICSI and in comparison to a normally conceived embryos the study also will question if the parameters of the prenatal biochemical standard parameters will have any differences if the embryo is already genetically tested embryo and compare these parameters with non PGS embryos and normally conceived embryos.
This study is an ambispective, comparative, cohort, observational, single-center study.
The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms
详细描述
This study is an ambispective, comparative, cohort, observational, single-center study that will be conducted at Wael ElBanna Clinic, a private center that is well equipped for all procedures needed for ICSI and fetal medicine. After obtaining informed consent, the study participants' relevant medical records will be collected and reviewed. Data will be collected from the subjects' medical records. Data will be pooled and presented in aggregate, without identification of individual subjects.
The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:
- Arm 1: biopsied ICSI embryos (PGS)
- Arm 2: none biopsied ICSI embryos
- Arm 3: natural pregnancy embryos
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnant women
- •Pregnancy confirmation by ultrasound at week 6 of gestation either by normal pregnancy or ICSI (Biopsied and Non-Biopsied)
- •Between the age of 20 and 40 years.
- •Non-smokers.
- •BMI must be between 19 and 40
排除标准
- •Those with anti-phospholipid syndrome confirmed by serological tests
- •Those with any hematological and immunological disorders
- •Women with uterine abnormalities have not been corrected.
- •Women with systemic diseases that cannot be controlled or managed
结局指标
主要结局
Third primary endpoint
时间窗: At 3rd trimester of pregnancy
- Third-trimester U/S measurements of fetal growth : U/S measurements of fetal growth using growth curves and measurement of FPI (fetal ponderal index) and fetal weight percentile
First primary endpoint
时间窗: At pregnancy
- Early ultrasound measurements "yolk sac (YS), mean sac diameter (MSD), crown rump length (CRL)", different maternal serum prenatal screening markers for growth and aneuploidy between the three arms\* of the study
Second primary endpoint
时间窗: At 2nd trimester of pregnancy
- Second trimetric U/S measurements of fetal growth : U/S measurements of fetal growth using growth curves and measurement of FPI (fetal ponderal index) and fetal weight percentile
次要结局
- First secondary endpoint(At Labor)
- Second secondary endpoint(At Labor)
- Third secondary endpoint(At Labor)
研究者
Wael Elbanna
European board fellow of obstetrics and gynecology
Wael Elbanna Clinic