A Randomised Controlled Trial to Explore the Effect of Physiological Intracytoplasmic Sperm Injection (PICSI) on Miscarriage Rates in Assisted Conception
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Miscarriage rate
研究概览
简要总结
Physiological intracytoplasmic sperm injection (PICSI) is a technique used to select healthy, mature sperm for use in infertility treatment based on their physiological ability to bind to hyaluronan (HA), a natural compound found in the body. The relationship between sperm and hyaluronan can be used a marker of sperm maturity and optimal fertilising potential; this principle can be observed in vitro using a PICSI sperm selection device. The PICSI Dish contains microdots of hyaluronan, which only mature sperm bind to and these are selected by the embryologist prior to use in the intracytoplasmic sperm injection (ICSI) procedure. Recurrent miscarriages following infertility treatment are mainly idiopathic, but can be linked with increased chromosomal abnormalities. PICSI has been shown to result in better embryo development and reduced chromosomal abnormalities, due to selection of mature sperm with low DNA damage. Therefore, PICSI may be a useful tool for reducing the rate of miscarriage following infertility treatment.
The recent HABSelect study investigated treatment outcomes following PICSI, and whilst they concluded no effect on livebirth rate, they found a significant association in their secondary analysis between PICSI and reduced miscarriage rate compared to ICSI. The implications of the HABSelect study deserve to be explored further with miscarriage rate assessed as a primary outcome measure. This proof-of-concept randomised-controlled-trial aims to investigate whether PICSI shows some promise that would merit evaluation in a fully-powered trial to assess its efficacy as an advanced sperm selection method for the reduction of miscarriage rate. Eligible study participants will be patients undergoing fertility treatment using ICSI, who have provided consent for PICSI. Patients will be randomly allocated to two groups: the control group will receive ICSI according to standard protocol, and the intervention group will have additional sperm selection by HA-binding in a PICSI dish.
详细描述
- INTRODUCTION 1.1 Background Physiological intracytoplasmic sperm injection (PICSI) is a technique used to select healthy, mature sperm for use in infertility treatment based on their physiological ability to bind to hyaluronic acid (HA), a natural compound found in the body. The relationship between sperm and HA can be used as a marker of sperm maturity and fertilising potential; this principle can be observed in vitro using a PICSI sperm selection device. The PICSI Dish contains microdots of hyaluronan, which only mature sperm bind to and these are selected by the embryologist prior to use in the intracytoplasmic sperm injection (ICSI) procedure.
The recent HABSelect study investigated treatment outcomes following PICSI, and whilst they concluded no effect on livebirth rate, they found a significant association in their secondary analysis between PICSI and reduced miscarriage rate compared to ICSI . The implications of the HABSelect study deserve to be explored further with miscarriage rate assessed as a primary outcome measure.
This proof-of-concept randomised-controlled-trial aims to investigate whether PICSI shows some promise that would merit evaluation in a fully-powered trial to assess its efficacy as an advanced sperm selection method for the reduction of miscarriage rate. Eligible study participants will be patients undergoing fertility treatment using ICSI, who have provided consent for PICSI. Patients will be randomly allocated to two groups: the control group will receive ICSI according to standard protocol, and the intervention group will have additional sperm selection by HA-binding in a PICSI dish.
1.2 Rationale Advanced sperm selection techniques have been developed to improve ART outcomes to select the healthiest, mature and structurally sound sperm. It is crucial that the best sperm are selected for ICSI, yet conventional sperm preparation methods, including density gradients, swim-up, and simple wash, are limited in their capacity to select for spermatozoa with maturity and reduced DNA fragmentation.
Recurrent miscarriages following infertility treatment are mainly resulting from unknown causes, but can be linked with increased chromosomal abnormalities from aneuploid embryos . Physiological Intracytoplasmic Sperm Injection (PICSI) is an advanced sperm selection method that selects for mature sperm with low DNA damage prior to injecting the oocytes in the ICSI procedure. PICSI has been shown to result in better embryo development and reduced chromosomal abnormalities. PICSI may be a useful tool for reducing the rate of miscarriage following infertility treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing ICSI as part of their treatment at the Shropshire and Mid-Wales Fertility Centre
- •A total of 140 couples coming through for treatment who have consented to the use of
- •PICSI in their treatment and participation in the PICSI study
- •Both parties providing gametes for use in treatment must give consent to participate in the study
排除标准
- •If testicular or frozen sperm samples are needing to be used
结局指标
主要结局
Miscarriage rate
时间窗: ≥37 weeks
The primary outcome measure is miscarriage rate, meaning the number of pregnancy losses following biochemical pregnancy (detection of urinary hcGH).
次要结局
- Blastocyst development and quality(5 and 6 days)
- Implantation rate(6-7 weeks)
- Live birth rate(≥37 weeks)
- Fertilisation rates(≥37 weeks)
- Embryo development and quality(two and three days)
- Biochemical pregnancy rate(6-7 weeks)