An Observational Study to Evaluate the Expression Profiles of Oocyte-potency-related Genes in Cumulus Cells of Women Treated With Human Recombinant FSH (Hr-FSH)and Triggered With GnRH Agonist in an Oocyte Donation Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Clinical evaluation: Day 3 embryo evaluation
研究概览
简要总结
This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist & hr-FSH with GnRH Agonist trigger, 2) Progesterone & hr-FSH with GnRH Agonist trigger.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Clinical evaluation: Day 3 embryo evaluation
时间窗: Day 3 of embryo culture
Day 3 embryo morphology evaluation according to the standard of care of the ART clinic
Clinical evaluation: number of cumulus-oocyte complex
时间窗: Day 1 of embryo culture
The number of cumulus-oocyte complex at time of pick-up
Clinical evaluation: Meiosis II oocytes
时间窗: Day 1 of embryo culture
The number of meiosis II oocytes (nominator) divided by the total number of oocytes retrieved (denominator)
Clinical evaluation: Abnormal fertilization
时间窗: Day 1 of embryo culture
The number of abnormal fertilized oocytes on day 1 at 17+1h post insemination, as a function of all COC's inseminated
Expression profile: blastocyst formation
时间窗: 2.5 years after study start
The expression profiles of cumulus of oocyte leading to a blastocyst and the expression profiles of cumulus of oocyte not leading to a blastocyst has been determined using RNA-Seq.
Basic clinical donor patient and stimulation characteristics: P4
时间窗: During ovarian stimulation (max 3 weeks)
Serum values for P4 (ng/ml)
Basic clinical donor patient and stimulation characteristics: Gonadotropin type and dose
时间窗: During ovarian stimulation (max 3 weeks)
Gonadotropin type and dose (IU) used for stimulation
Clinical evaluation: number of Follicles
时间窗: During ovarian stimulation (max 3 weeks)
The number of follicles at time of trigger (oocyte-pick-up day-2)
Basic clinical donor patient and stimulation characteristics: E2
时间窗: During ovarian stimulation (max 3 weeks)
Serum values for E2 (ng/L)
Clinical evaluation: Normal Fertilization
时间窗: Day 1 of embryo culture
The number of fertilized oocytes on day 1 (presence of 2PN and 2PB assessed at 17 + 1h post-insemination), as a function of all COC's inseminate
Clinical evaluation: Day 5/6 embryo evaluation
时间窗: Day 6 of embryo culture
Day 5/6 embryo evaluation based on the criteria of Gardner and Schoolcraft (Gardner and Schoolcraft 1999)
Clinical evaluation: Embryo utilization
时间窗: Day 6 of embryo culture
Defined as the number of blastocyst suitable for cryopreservation and transfer as a function of the number of normally fertilized (2PN) oocytes observed on day 1 (ESHRE Special Interest Group Alpha Scientists 2017)
Clinical evaluation: Day5/6 good quality blastocyst rate
时间窗: Day 6 of embryo culture
Defined as the proportion of 2PN zygotes which are good-quality blastocyst on Day 5/6 (116 +-2h and 140 +-2h post-insemination) (ESHRE Special Interest Group of Embryology and Alpha Scientists in Reproductive Medicine 2017)
次要结局
- Normalized messenger ribonucleic acid (mRNA) expression(2.5 years after study start)
- Biochemical pregnancy(Day 10 after embryo transfer)
- Expression profile: pregnancy prediction(2.5 years after study start)
- Clinical pregnancy with positive fetal heartbeat(week 5-6 after embryo transfer)