Progesterone Diurnal Rhythm During Ovarian Stimulation for IVF
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Progesterone levels during follicular phase
研究概览
简要总结
To evaluate the influence of circadian rhythm on progesterone levels during follicular phase of natural cycle and during follicular phase of controlled ovarian stimulation during IVF.
详细描述
The primary aim of this study is to determine the circadian rhythm of progesterone in a stimulated cycle. Sample size calculations show that the study needs to recruit 10 women to show any significant differences in progesterone secreted in the morning at 8 am compared to that secreted in the evening at 8 pm. We have increased the number of participants to 12 in order to compensate for any possible drop outs. The hormones FSH, LH, Progesterone and Estradiol will be measured at days 2/3, 8, 10 and 12 of a normal and stimulated cycle so that each patient serves as her own control.
This study will provide the basis to establish the optimal blood sampling time for progesterone measurement and to more accurately determine the cut-off level for progesterone for favourable pregnancy outcomes in ART.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Indication for IVF / ICSI - treatment
- •Age ≥ 18 years and ≤ 35 years
- •Ovarian reserve parameters in the adequate age - range, determined by Anti-Mullerian-Hormone (AMH) and Antral Follicle Count (AFC)(16)
- •Able to understand the aim of the study and to provide consent
- •Regular cycle (25-35 days)
排除标准
- •Diagnosis of polycystic ovarian syndrome (PCOS) Rotterdam criteria
- •Endometriosis stage 3 or 4 AFS
- •Treatment with GnRH-analogues during the previous 6 months
- •Intake of oral contraceptive pill (OCP) or any hormonal treatment during the last 3 months
结局指标
主要结局
Progesterone levels during follicular phase
时间窗: 2-4 months
The primary aim of this study is to determine the circadian rhythm of progesterone in a stimulated cycle.
次要结局
未报告次要终点
研究者
Prof Dr. Human Fatemi
Medical Director
ART Fertility Clinics LLC