Impact of Step-down Approach During Late Follicular Phase in Recombinant FSH-stimulation Dosage for IVF on Progesterone Level on the Day of Final Oocyte Maturation
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Impact of dose reduction in recFSH for IVF on the progesterone level.
研究概览
简要总结
Step-down approach and late follicular phase progesterone level
详细描述
The study will be performed using the stimulation medication Gonal-F which is a recombinant FSH-preparation. Due to application as pen-device, it allows reduction of the stimulation dosage in steps of 12.5IU.
It is important to evaluate the dynamics of progesterone-rise after final oocyte maturation, as this dynamic might also have an influence on the receptivity of the endometrium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Primary / secondary infertility with the indication for IVF/ICSI
- •Patients age 18 - 40 years
- •60 kg up to and including 90 kg
- •BMI of 18-32 kg/m2
- •Menstrual cycle length of 24-35 days
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Exclusion criteria:
- •presence or history of an endocrine abnormality
- •abnormal outcome of blood biochemistry or hematology
- •relevant ovarian-, tubal- or uterine-pathology that could interfere with the ovarian stimulation treatment
- •history of ovarian hyper-response (more than 30 follicles ≥ 11 mm) or ovarian hyper-stimulation syndrome (OHSS), polycystic ovary syndrome (PCOS)
- •History of poor ovarian response, according to the Rotterdam-criteria (Ferrarretti et al.)
- •ovarian reserve parameter, indicating the risk of poor ovarian response (AFC < 5 and AMH < 0,5ng/ml) (14)
研究组 & 干预措施
Control group
Follicle stimulating Hormone will be applied, starting from day 3 of the cycle, the dosage will be choosen between Gonal F 150 - 225 IU, according to the ovarian reserve parameters (13). The stimulation dosage will remain unchanged until the criteria for final oocyte maturation are met (≥ 3 follicles of ≥ 17 mm).
干预措施: follicle stimulating hormone (Drug)
Study group
Follicle stimulating Hormone will be applied, starting from day 3 of the cycle, the dosage will be choosen between Gonal F 150 - 225 IU, according to the ovarian reserve parameters (LaMarca et al.). As soon as ≥ 3 follicle of a size of 14mm are seen, the stimulation dosage will be reduced daily by 12.5 IU recFSH until the criteria for final oocyte maturation are met (≥ 3 follicles of ≥ 17 mm).
干预措施: follicle stimulating hormone (Drug)
结局指标
主要结局
Impact of dose reduction in recFSH for IVF on the progesterone level.
时间窗: 1year and 6 months
Whether higher progesterone levels on the day of trigger will lead to rapid rise of progesterone after ovulation induction compared to lower progesterone levels.
次要结局
未报告次要终点
研究者
Prof Dr. Human Fatemi
Professor Doctor
ART Fertility Clinics LLC