NCT02809989已完成不适用
Multicentre, Prospective, Open, Non-interventional Study to Evaluate the Effect of Ovaleap® on the Pregnancy Rate and Clinical Effects as Well as the User-friendliness of the Ovaleap®-Pen in the Clinical Routine of the IVF- / ICSI-treatment.
Teva Pharma GmbH37 个研究点 分布在 1 个国家目标入组 507 人开始时间: 2016年3月31日最近更新:
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
- 发起方
- 入组人数
- 507
- 试验地点
- 37
- 主要终点
- Number of retrieved oocytes after ovarian stimulation therapy
研究概览
简要总结
The aim of this non-interventional study is to extend the knowledge on effectiveness of Ovaleap® (number of oocytes and pregnancy rate) during routine IVF- or ICSI-treatment using a Gonadotropin-releasing hormone (GnRH) antagonist protocol in a large number of patients.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a medical indication for an ovarian stimulation therapy for the purposes of an IVF or ICSI.
- •First-time ovarian stimulating therapy for an IVF or ICSI.
- •Ovarian stimulation therapy exclusively with Ovaleap®.
- •GnRH antagonist protocol.
- •Body-Mass-Index (BMI) < 30 kg/m
- •Duration of menstrual cycle 24 - 35 days.
- •Additional criteria apply, please contact the investigator for more information
排除标准
- •Combined application of IVF and ICSI
- •Ovarian hyperstimulation with Ovaleap® with a consecutive "social freezing".
- •Polycystic ovary syndrome (PCOS).
- •Endometriosis (AFS (American Fertility Society) grade 3 and 4).
- •Uterine myoma (intramural > 4 cm, submucosal).
- •Hydrosalpinx (on one side or both sides).
研究组 & 干预措施
Ovaleap®
Single group prospective treatment cohort
干预措施: Ovaleap® (Drug)
结局指标
主要结局
Number of retrieved oocytes after ovarian stimulation therapy
时间窗: 12 months
Clinical pregnancy rate
时间窗: 12 months
次要结局
- Number of days with administration of Ovaleap®(12 months)
- Endometrial thickness (mm) at time of the last sonography prior to induction of ovulation(12 months)
- Used drugs for induction of the ovulation (recombinant Human chorionic gonadotropin (HCG), urinary HCG, GnRH agonist)(12 months)
- Number of Metaphase II (MII)-oocytes(12 months)
- Percentage fertilisation rate(12 months)
- Day of embryo transfer (relative to the day of follicle puncture) and number of transferred embryos(12 months)
- Luteal phase support (LPS): product, dose and duration of administration(12 months)
- Frequency and intensity of adverse drug reactions (ADRs)(12 months)
- Rate of multiple pregnancies (twins, triplets, quadruplets).(12 months)
- Level of serum estradiol at the time of the last examination prior to induction of ovulation(12 months)
- "Baby-Take-Home-Rate" (live-births).(12 months)
- Administered total dose of Ovaleap®(12 months)
- User satisfaction with the Ovaleap®-pen(12 months)
研究者
研究点 (37)
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