Early Follicular Phase Androstenedione Monitoring During Low-dose Step-up Induction of Ovulation in High Responders
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood androstenedione and testosterone levels.
研究概览
简要总结
This study aims to predefine the threshold FSH doses during the early follicular phases in low- dose step-up ovulation induction cycles used to treat anticipated high responders by monitoring total testosterone and androstenedione blood levels. The blood levels of total testosterone and androstenedione levels will be measured in patients at the starting day and at every control day when vaginal sonographic folliculometries and blood estradiol measurements are made. Hence, we are aiming to define an early monitoring parameter by which we will be able to define a follicular response to treatment before estradiol rise or apparently selected follicular growth.
详细描述
50 patients with anticipated high ovarian response, who are being planned to be conventionally treated with low-dose step-up ovulation induction and intrauterine insemination will be analysed in this study. At every control day including the start day, blood samples taken for blood estradiol (and if required progesterone) measurements will be used to measure blood androstenedione and total testosterone levels, as well. Hence, we will have defined an early parameter for defining follicular response in the first 5-7 days of low-dose step-up ovulation induction. Low-dose step-up ovulation induction will be started at 50-75Units/day of rhFSH and the dose will be increased at not earlier than the 7th day at an increment of +37,5Units/day unless a response is observed ( which is at least a 10mm follicle, selected for growth). If more than 3 dominant follicles are selected, the cycle will be cancelled. Otherwise, when at least one follicle >16mm is obtained, a 150Microgram sc. injection will be administered for ovulation trigger and intrauterine insemination made at the 34th-36th hours.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primary/Secondary infertile women; aged 20-35 years of age
- •High ovarian response to ovulation induction anticipated.(Antral follicle count on the 3rd day of cycle>10)
- •Mild male factor or normal sperm parameters
- •Normal anatomic findings with the HSG
- •Eugonadotropic
- •Normal blood prolactin and TSH levels
排除标准
- •Amenorrheic women
- •Women with Diabetes Mellitus
- •Body Mass Index: <22 or >30
- •Age<20 or >35 years old
- •Hormonal abnormalities: regarding prolactin, TSH
- •Hypo- or Hypergonadotropic women
- •Additional medical or surgical disease
- •Ovarian cysts
- •Previous ovarian surgery
结局指标
主要结局
Blood androstenedione and testosterone levels.
时间窗: within 10-20 days
Patterns of blood androstenedione and testosterone levels with respect to the regular monitoring parameters and relations to secondary outcomes.
次要结局
- Pregnancy(20-30 days)
- Cycle cancellation(within 10-20 days)
- Ovarian hyperstimulation(10-30 days)
- Need for dose step-up(7-14 days)
研究者
Eser Sefik Ozyurek
Operator Doctor
Bagcilar Training and Research Hospital