NCT06617988尚未招募不适用
Investigate Differences in SIRT3 Expression in Granulosa Cells and the Levels of Follicular Fluid Metabolites Among Poor Ovarian Responders Subgroups, and Their Association with IVF Outcomes.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The relative expression level of SIRT3 mRNA of granulosa cells
研究概览
简要总结
The goal of this prospective, observational study is to learn about the pathogenesis and biological target of the subtypes of poor ovarian response (POR) during In vitro fertilization and embryo transfer (IVF-ET). The main question it aims to answer is:
- Can the relative expression level of SIRT3 differentiate between POR subtypes, and do these differences reflect distinct metabolic characteristics among the subtypes?
- Investigate whether SIRT3 expression levels correlate with clinical outcomes. This study will enroll patients with various POR subtypes and collect discarded follicular fluid and granulosa cells on the day of egg retrieval. IVF outcome information routinely collected in electronic databases will also be recorded. Notably, this is a purely observational study with no additional interventions. Your participation will not alter your clinical treatment compared to other patients.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are married and aged between 20 to 45 years, diagnosed with infertility;
- •Individuals undergoing their first or second cycle of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), with a scheduled fresh embryo transfer;
- •Participants must fulfill the diagnostic criteria corresponding to one of the following prognostic categories as determined by the clinician: Normal prognosis, unexpected poor prognosis, poor prognosis of advanced maternal age, or expected poor prognosis.
排除标准
- •A body mass index (BMI) of ≥ 35 kg/m²;
- •Participation in cycles involving pre-implantation genetic testing or diagnosis of embryos;
- •Involvement in cycles utilizing frozen gametes;
- •Engagement in cycles that employ donor-derived oocytes;
- •Participation in in vitro maturation cycles;
- •6.The presence of uterine cavity or endometrial abnormalities, including but not limited to fibroids, endometrial polyps, malformations, adenomyomas, endometritis, endometrial thinning, hydrosalpinx, uterine infections;
- •7.The existence of contraindications to assisted reproductive technology or pregnancy, such as uncontrolled liver or kidney dysfunction, diabetes mellitus (with glycated hemoglobin ≤ 7% and fasting blood glucose < 10 mmol/L), hypertension, thyroid disorders, asymptomatic cardiac conditions, moderate-to-severe anemia, malignancies, a history of thromboembolism or thrombosis, severe mental health disorders, acute infections of the urinary and reproductive systems, sexually transmitted infections, and detrimental lifestyle factors including substance abuse. Additionally, exposure to teratogenic levels of radiation, toxins, or medications (such as prednisone, other hormones, adrenaline, antibiotics, or medications for hypertension, cardiovascular issues, or antiviral treatment) during surgical procedures, as well as any physical conditions rendering pregnancy inadvisable, are also considered disqualifying factors.
结局指标
主要结局
The relative expression level of SIRT3 mRNA of granulosa cells
时间窗: Detected within three days after oocyte retrieval
The real-time quantitative PCR methods were used to test the relative expression level of SIRT3 mRNA of granulosa cells of each participant among groups.
次要结局
- Positive pregnancy rate(2 weeks after the day of embryo transfer)
- Embryo implantation rate(3 weeks after the day of embryo transfer)
- Clinical pregnancy rate(4 weeks after the day of embryo transfer)
- Number of oocytes retrieved(Within 1 day after the oocyte retrieval)
- Average daily dose of gonadotropin per COS cycle(Through the process of controlled ovarian stimulation, an average of 10 days)
- Total dosage of gonadotropin per COS cycle(Through the process of controlled ovarian stimulation, an average of 10 days)
研究者
Jing-Yan Song
Doctor
Shandong University of Traditional Chinese Medicine
研究点 (1)
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