The Effect of Melatonin Supplementation on Cumulus Cells and Reproductive Outcomes in Older Women Undergoing IVF Cycles
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- oxygen consumption rate of mitochodria (%)
研究概览
简要总结
This study investigates the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. Cumulus cells will be collected after oocyte retrieval, and IVF outcomes will be assessed.
详细描述
Aging in female reproductive cells, particularly cumulus granulosa cells, is associated with various dysfunctions that compromise fertility. Melatonin, a hormone primarily produced by the pineal gland, is renowned for its multifaceted roles in regulating physiological processes, including sleep-wake cycles, immune function, and antioxidative defense. Melatonin's antioxidant action is mediated through direct scavenging of free radicals, upregulation of antioxidant enzymes, and improvement of mitochondrial efficiency. These properties make melatonin a promising candidate for mitigating the adverse effects of aging on cellular function. This study aims to explore the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. In the control group, patients will proceed directly to IVF cycles without melatonin supplementation. Cumulus cells will be collected after oocyte retrieval, and gene expression will be measured. Additionally, clinical pregnancy rate, live birth rate, and miscarriage rate between the two groups will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 35-45 years
- •BMI 18-30 kg/m2
- •planning to undergo IVF cycles
排除标准
- •Primary ovarian insufficiency
- •history of oophorectomy
- •receiving oocyte donation
- •Chromosome anomaly
- •Congenital uterine anomaly
- •Severe intrauterine adhesion
- •Malignancy
- •Using hormone therapy or supplements in recent 3 months
研究组 & 干预措施
Control group
Patients did not receive melatonin supplementation and proceeded directly to IVF cycles
Melatonin group
Patients received melatonin supplementation for at least a two-month period prior to IVF cycles
干预措施: Melatonin (Dietary Supplement)
结局指标
主要结局
oxygen consumption rate of mitochodria (%)
时间窗: through study completion, an average of 4 year
to assess mitocondrial function in cumulus cells
Live birth rate (%)
时间窗: through study completion, an average of 4 year
a viable infant after 24 weeks of gestation
mRNA levels of cumulus cell genes
时间窗: through study completion, an average of 4 year
to assess cumulus cells gene expression analysis
次要结局
- Clinical pregnancy rate (%)(through study completion, an average of 4 year)
- Ongoing pregnancy rate (%)(through study completion, an average of 4 year)
- Amount of ATP production (moles/min) of mitochodria(through study completion, an average of 4 year)
研究者
Li-Te Lin
Attending doctor, Department of Obstetrics and Gynecology, Principal Investigator, Associate professor
Kaohsiung Veterans General Hospital.