A Randomized Double-blind Controlled Study of the Cumulative Live Birth Rate of IVF Following Sperm Preparation by Microfluidic Chip Method Versus Density-gradient Centrifugation Method
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,136
- 试验地点
- 1
- 主要终点
- cumulative live birth rate
研究概览
简要总结
Infertile patients attending IVF treatment at the Centre of Assisted Reproduction and Embryology, Queen Mary Hospital and Kwong Wah Hospital will be recruited during ovarian stimulation for IVF. Subsequently, they will be randomly assigned on the day of oocyte retrieval by a laboratory staff into one of the following two groups: (1) the microfluidic chip group and (2) the density gradient group for sperm preparation and subsequent use in fertilization. Other IVF procedures will be the same as our usual practice. Both patients and clinicians were blinded from the group allocation i.e. a double blind study. The primary outcome is the cumulative live birth rate defined as the number of pregnancies leading to live birth within 6 months of randomisation.
详细描述
The trial will compare the use of a microfluidic chip with the use of density gradient centrifugation for sperm preparation.
The hypothesis of the study is that the use of the microfluidic chip will improve the cumulative live birth rate of IVF compared to the density gradient method.
The trial will be conducted at the Centre of Assisted Reproduction and Embryology at Queen Mary Hospital and Kwong Wah Hospital. Infertile patients undergoing IVF treatment will be recruited during ovarian stimulation. They will be randomly assigned to one of two groups: the microfluidic chip group or the density gradient group. Both the patients and the clinicians will be blinded to the group allocation.
The inclusion criteria for the study are infertile women aged under 43 years undergoing ovarian stimulation for IVF. The exclusion criteria include women undergoing certain genetic testing, male factor infertility requiring surgical sperm retrieval, the use of donor oocytes and spermatozoa, certain uterine conditions, previous participation in the study, and participation in other randomized trials.
The eligible women will undergo standard IVF procedures, including ovarian stimulation, monitoring of follicle growth, trigger for oocyte retrieval, and oocyte retrieval itself. On the day of oocyte retrieval, the women will be randomly assigned to either the microfluidic chip group or the density gradient group for sperm preparation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Both patients and clinicians were blinded from the group allocation i.e. a double blind study.
入排标准
- 年龄范围
- — 至 43 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infertile women aged <43 years at the time of ovarian stimulation for IVF
排除标准
- •Women undergoing preimplantation genetic testing monogenic diseases, structural rearrangement of chromosomes or aneuploidy;
- •Male factor requiring surgical sperm retrieval such as microscopic epididymal sperm aspiration and testicular sperm extraction;
- •Use of donor oocytes and spermatozoa;
- •Submucosal fibroid or hydrosalpinx shown on pelvic scanning and not surgically treated;
- •Women who had been recruited into this study before and
- •Women joining other randomized trials
研究组 & 干预措施
microfluidic chip method
Microfluidic chip method has been used for sperm sorting in order to select the most motile and morphologically normal sperm for use in assisted reproductive technologies (ART) such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI).
In the microfluidic chip method for sperm sorting, a small amount of semen sample is loaded onto the chip, which contains channels and chambers that allow for the separation of sperm based on their motility and morphology. The chip is designed to mimic the natural environment of the female reproductive tract, where sperm undergo a series of selection processes before reaching the egg.
干预措施: Microfluidic chip (Device)
density-gradient centrifugation method
Density-gradient centrifugation is a commonly used method for sperm separation and purification. It is a technique that involves layering a semen sample on top of a gradient of different densities of a solution, typically a mixture of colloidal silica and sucrose, and then centrifuging the sample. The centrifugal force causes the sperm to migrate through the gradient, where they become separated based on their density.
干预措施: Density-gradient centrifugation (Device)
结局指标
主要结局
cumulative live birth rate
时间窗: within 6 months of randomisation.
cumulative live birth rate defined as the number of pregnancies leading to live birth within 6 months of randomisation.
次要结局
- Live birth beyond 22 weeks of gestation per the first embryo transfer or FET(3 years)
- Ectopic pregnancy rate(3 years)
- Clinical pregnancy per the first embryo transfer or FET defined as presence of intrauterine gestational sac on scanning at gestational week 6.(3 years)
- Miscarriage defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy and whose denominator is the clinical pregnancy.(3 years)
- Multiple pregnancy: presence of more than one intrauterine sac at 6 weeks of gestation(3 years)
- Positive urine pregnancy test per the first embryo transfer or FET(3 years)
- Ongoing pregnancy rate as presence of a fetal pole with pulsation at 8-10 weeks of gestation(3 years)
研究者
Professor Ernest Hung-Yu Ng
Clinical Professor
The University of Hong Kong