Assessment of the Role of Serum FSH Monitoring During Ovarian Stimulation and Identification of an Optimal Range for Expected Normal Responders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Quantitative Measurement of Serum Follicle-Stimulating Hormone (FSH) Levels During Ovarian Stimulation Using Serum Assays.
研究概览
简要总结
This study examines if monitoring serum Follicle Stimulation Hormone (FSH) levels can predict oocyte yield and progesterone levels, considering factors like age, baseline FSH, Antral Mullerian Hormone (AMH), antral follicle count, body weight, kidney function, and urinary FSH. The aim is to find a minimum FSH level that ensures optimal ovarian response and enables tailored FSH dosages for better outcomes.
详细描述
Ovarian stimulation typically uses transvaginal ultrasound to monitor follicle growth and endometrial condition, with some clinics also tracking serum estradiol and progesterone levels, but often neglecting serum Follicle Stimulation Hormone (FSH). FSH is essential for follicle development, yet its levels can vary widely among women receiving the same dose due to factors like body weight, renal function, and ovarian reserve.
This study aims to identify a minimum effective FSH threshold that ensures optimal follicular growth while avoiding excess administration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •regular 21 - 35 days cycles
- •BMI between 19 - 30 kg/m2
- •serum AMH level between 1.5 to 3 ng/ml
- •a total antral follicle count between 10 to 24
- •endogenous early follicular phase serum FSH level <10 IU/L
- •normal glomerular filtration rate
排除标准
- •hypogonadotropic hypogonadism
- •history of ovarian surgery
- •permanent ovarian cysts of any form
- •older than 39 years
- •abnormal thyroid stimulating hormone (TSH)
- •renal disease
- •elevated prolactin levels
- •intake of oral contraceptives 3 months before stimulation start and estradiol pretreatment will be excluded
研究组 & 干预措施
FSH Monitoring Group
Women undergoing ovarian stimulation will be given preselected constant gonadotropin dosage and an association between serum FSH (follicular stimulating hormone) levels during stimulation and response will be assessed.
Blood samples will be taken (along with clinical standard routine) on day 2/3 of cycle, day 5 / 8 and 10 of stimulation and on the day of trigger (DoT). Urine samples will be taken additionally.
Final oocyte maturation will be triggered with 250 mcg recombinant human Choriogonadotropin and 0.2 mg Decapeptyl as soon as >2 follicles reach 17 mm diameter.
Women who have more than 30 follicles ≥12 mm and or serum estradiol levels above>5000 pg/ml on the day of trigger will only be triggered with Decapeptyl. OPU (oocyte pick up) will be 36 h after trigger.
On the day of oocyte collection (OPU), follicular fluid from the largest follicle will be checked for FSH level after the cumulus oocyte complex is removed.
干预措施: Gonal-f (gonadotropin) (Drug)
结局指标
主要结局
Quantitative Measurement of Serum Follicle-Stimulating Hormone (FSH) Levels During Ovarian Stimulation Using Serum Assays.
时间窗: 1 year
serum FSH levels during ovarian stimulation
次要结局
未报告次要终点