Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles
研究概览
简要总结
This randomized controlled trial has been designed for carrying out a comparison of new AMH (Anti-Müllerian Hormone)-based individualized treatment (using a nomogram) with the wide accepted age-based strategy. The main objective of the trial is to assess whether an individualized FSH starting dose can increase the rate of women with an adequate ovarian response in terms of retrieved oocytes (optimal number of retrieved oocytes: 8-14).
详细描述
Before clinicians can adopt any model into routine clinical practice, the accuracy of the model should be independently evaluated in a population different from the one on which the model was elaborated. External validation of the model is therefore crucial to assess the generalizability to other populations.
In the present RCT the new AMH-based individualized treatment will be compared to the wide accepted age-based strategy.
Primary endpoint:
The percentage of women with an appropriate number (n=8-14) of retrieved oocytes in IVF/ICSI cycle.
Secondary endpoints:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •first or second IVF/ICSI attempt (the second one after 6 months from the first one);regular menstrual cycles (25-33 days);female age ≤ 40; day 3 FSH ≤ 15IU/L;treatment with a long GnRH agonist protocol (buserelin)+rFSH;BMI: >18 and ≤ 25 kg/m2;presence of both ovaries.
排除标准
- •irregular cycles, anovulatory infertility, endometriosis III-IV stage AFS, use of adjunctive therapies for stimulation, evidence of PCO status, previous ovarian surgery, presence of ovarian cysts, history of PID, use of hormonal contraception in the previous 3 months, any known metabolic or endocrinological disease, AMH levels < 1 and > 4.0 ng/ml
研究组 & 干预措施
Group A: "age"
Group A: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle, until the end of gonadotropin administration) + 150 IU of rFSH (starting dose) if female age was ≤35 years or 225 IU of rFSH if female age was ≥ 36 years.
干预措施: rFSH (Drug)
Group A: "age"
Group A: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle, until the end of gonadotropin administration) + 150 IU of rFSH (starting dose) if female age was ≤35 years or 225 IU of rFSH if female age was ≥ 36 years.
干预措施: buserelin (Drug)
Group B: "nomogram"
Group B: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle until the end of gonadotropin administration) + individualized starting dose of rFSH on the basis of the nomogram.
干预措施: rFSH (Drug)
Group B: "nomogram"
Group B: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle until the end of gonadotropin administration) + individualized starting dose of rFSH on the basis of the nomogram.
干预措施: buserelin (Drug)
结局指标
主要结局
The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles
时间窗: 24 months
次要结局
未报告次要终点