NCT04710264已完成不适用
An Observational Cohort Study to Evaluate the Expression Profiles of Oocyte-potency-related Genes in Ovarian Cumulus Cells From Patients Treated by Intracytoplasmic Sperm Injection (ICSI) That Are Treated With Recombinant Gonadotropins
Fertiga, Belgium1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2021年2月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Normalized messenger ribonucleic acid (mRNA) expression
研究概览
简要总结
This is an observational study. The main aim is to determine the expression of potential biomarker genes in the cumulus cells isolated from individual oocytes in two patient cohorts: recombinant human Follicle Stimulating Hormone(hFSH) and recombinant hFSH:human Luteinizing Hormone(r-hLH) ratio 2:1. Algorithms from gene combinations will be identified that predict embryo quality and pregnancy outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients are between 22-38 years old
- •BMI between 17-33
- •provide written informed consent
- •Patients undergoing a first or second ICSI treatment cycle.
- •Patients will be treated by ICSI (intracytoplasmic sperm injection)
- •Patients agree that the oocytes will be denuded for cumulus testing and agree to the single blastocyst transfer.
- •Patients must be predicted good ovarian responders (AMH 1-4,7 ng/ml) with 7-18 follicles of minimum 10-11 mm on trigger day (oocyte retrieval minus 2 days (OR -2)) by ultrasound following ovarian stimulation with r-hFSH or r-hFSH with r-hLH in a Gonadotropin-releasing hormone (GnRH) antagonist protocol (starting dose recombinant Follicle Stimulating Hormone (rFSH) between 150-225 IU)
- •HCG trigger after stimulation (r-hCG)
排除标准
- •Women with less than 7 or more than 18 follicles at Day -2 or -3 measured by ultrasound
- •Women with history of poor oocyte maturation or known maturation defect
- •Irregular menstrual cycle (< 24 or > 35 days)
- •BMI < 17 or > 33
- •Smoking > 10 cigarettes per day.
- •Known low ovarian response based on Bologna criteria
- •Combined use of urinary and recombinant gonadotropins in the current cycle
- •Patients with severe endometriosis ≥ III (AFS classification)
- •Polycystic ovary syndrome (PCOS), defined by revised criteria American Society for Reproductive Medicine (ASRM) European Society of Human Reproduction and Embryology (ESHRE) 2018
- •Patient included in any other study
- •Patient scheduled for preimplantation genetic testing (PGT)
- •Testicular sperm extraction (TESE) or extreme oligo-astheno-teratozoospermia (OAT) with sperm count below 100.000/ml.
结局指标
主要结局
Normalized messenger ribonucleic acid (mRNA) expression
时间窗: 3 years after study start
Normalized mRNA levels of biomarker genes that are assessed in cumulus cells by reverse transcription quantitative Polymerase Chain Reaction (RT-qPCR) for each oocyte.
次要结局
- Ongoing pregnancy rate(Week 10-11 after embryo transfer)
- Meiosis II Oocyte rate(Day 0 of embryo collection)
- Normal fertilization rate(Day 1 of embryo culture)
- Embryo utilization rate(Day 5 of embryo culture)
- Clinical pregnancy rate(Week 5-6 after embryo transfer)
- Day 5 good-quality embryo rate(Day 5 of embryo culture)
- Biochemical pregnancy rate(Day 10 after embryo transfer)
- Fetal heart beat positive implantation rate(Week 5-6 after embryo transfer)
- Miscarriage rate(Week 12 after embryo transfer)
研究者
研究点 (1)
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