NCT02935335已完成不适用
Relationship Between antimüllerian Hormone Measured by a Fully Automated Assay and the Initial Dose of HP-hMG (Menopur®) Prescribed for Infertile Women Undergoing Their First IVF/ICSI Cycle.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 1
- 主要终点
- Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels
研究概览
简要总结
AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for infertile women undergoing their first IVF/ICSI cycle in the current practice.
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
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between [18-42] years.
- •Both ovaries present.
- •Regular menstrual cycles presumed to be ovulatory.
- •Primary or secondary infertility of any origin for more than 12 months.
- •Patient with at least one result of antimüllerian hormone (AMH) measured by a fully automated assay available before inclusion, and performed in the past 12 months before inclusion.
- •Candidates eligible to a first IVF/ICSI cycle and for whom Menopur® HP-hMG 600 IU/mL has been prescribed.
- •Having received oral and written information on the study, without any objections for the use of his/her anonymized data, and having signed a written Informed Consent Form.
排除标准
- •Major uterine or ovarian morphological abnormalities or past ovarian surgery.
- •Endometriosis stage III/IV.
- •Polycystic ovarian syndrome.
- •Major endocrine or metabolic abnormalities without treatment.
- •Patient included in an interventional study assessing treatment for infertility.
研究组 & 干预措施
Menopur® HP-hMG
Treatment according to routine clinical practice.
干预措施: Menotrophin (Drug)
结局指标
主要结局
Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels
时间窗: At baseline (inclusion)
次要结局
未报告次要终点
研究者
研究点 (1)
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