Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- between cycle reliability of ovarian reserve assessment based on AMH serum concentration
研究概览
简要总结
The developement of a new, stable measurement of the Antimuellerian Hormon (AMH) together with Roche Diagnostics International (Rotkreuz, CH) shall enable an automized and timely measurement of AMH values in blood samples.
详细描述
An important requirement for the use of the new measurement to determine the AMH concentration is the stability of the AMH level over the menstrual cycle. So far the unbiased AMH concentration is the most important argument to manage this parameter.
There are several studies, which give different professional opinions of the AMH concentration depending on the phase of the menstrual cycle. Some authors came to the conclusion that the AMH concentration over the menstrual cycle is constant, others described significant fluctuations. It is unclear, if the described fluctuation is relevant for the interpretation of the ovarian reserve. Recently it could be shown, that intraindividual fluctuations of joung women during the menstrual cycle is stronger, which means that the measurement of AMH in this age is less secure.
The primary goal of the study is to evaluate, if the new AMH measurement with the ElecSys method delivers stable values over the menstrual cycle.
The secondary goal of the study is to determine whether there are any fluctuations in the number of antral follicles as given by 3D ultrasound.
For this reason we are recruiting a group of 50 women within two categories of age to measure eventually changes in AMH- concentration during their menstrual cycle.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Regular natural menstrual cycle between 24 and 32 days
- •Body Mass Index (BMI) between 19 and 26 kg/m2
- •Negative serum titer for HIV, Hepatitis B and Hepatitis C
- •Non-smoker
- •Willingness to visit the clinic every second day of two non-consecutive menstrual cycles.
排除标准
- •Intake of hormonal medication like contraceptives
- •Pregnancy/breast feeding
- •Known infertility
- •Known former or actual hormonal disorder
- •Polycystic ovarial syndrom (PCOS)
- •Participation on another clinical trial during the last 3 months.
结局指标
主要结局
between cycle reliability of ovarian reserve assessment based on AMH serum concentration
时间窗: 3 months
stabile assessment of ovarian reserve with AMH (pmol/l) in blood
次要结局
- number of ovarian follicles as made visible by 3D ultrasound(3 months)
研究者
Christian De Geyter
Professor
University Hospital, Basel, Switzerland