褪黑素联合 DHEA 治疗卵巢储备功能下降的临床试验
试验速览
- 阶段
- 治疗新技术临床试验
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Embryological outcomes
研究概览
简要总结
The aim of the study is whether oral melatonin plus DHEA administration can improve the outcome of IVF in Diminished Ovarian Reserve (DOR) patients as follows: To determine embryological outcome; To determine biochemical outcome (to find out optimum hormono-microfollicular enviroment for high quality oocyte through comparing Melatonin, Estrogen, Progestrogen and LH in follicular fluidin leading follicles of different group patients including PCOS, Normal Ovarian Reserve, DOR patients with or without Melatonin plus DHEA treated).
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 横断面
入排标准
- 年龄范围
- 20 至 52（—）
- 性别
- Female
入选标准
- •For DOR patient:
- •The criteria for DOR included AMH, FSH and Estradiol (E2) levels as well as antral follicle counts (AFC) or retrieved oocyte number. The patients were considered to have DOR if they have had serum AMH levels ≤ 1 ng/ml or an AFC≤5 on Day 3 of a spontaneous cycle or retrieved oocyte number ≤
- •For NOR patient (Normal Ovarian Reserve):
- •The criteria for Normal Ovarian Reserve (NOR) patients included AMH>3 ng/ml, FSH≤10 IU/ml, an AFC≥8 and or retrieved oocyte number ≥
- •For PCOS patient:
- •The criteria for PCOS patients included AMH>10 ng/ml, FSH/LH ratio >2, AFC for each ovaries ≥ 12(Total ≥ 25) and or retrieved oocyte number ≥ 15 or clinical and/or biochemical signs of hyperandrogenism.
排除标准
- •The patients with known conditions affecting ovarian reserve, including ovarian surgery, polycystic ovarian syndrome, endometriosis, post chemo and radiation therapy recovery or BMI ≥ 25 will be excluded.
研究组 & 干预措施
1（随机分组）
Daily melatonin dosage is 4 mg capsule orally, take at 22:00–23:00 pm, in accordance with the studies of Tamura et al. and Simpson et al. Administration of melatonin will begin from the 5th day of the Menstrual cycle until the human chorionic gonadotropin (hCG) injection day of the controlled ovarian
2（随机分组）
without treatment
3（不参与随机分组）
without treatment
4（不参与随机分组）
without treatment
结局指标
主要结局
Embryological outcomes
时间窗: oocyte quality, fertilization rate and embryo quality for each patients
次要结局
- 生化指标(Melatonin, LH, Estrogen, Progesterone levels in follicular fluid in leading follicle at the time of oocyte collection)