Prospective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,195
- 试验地点
- 1
- 主要终点
- Number of oocytes retrieved
研究概览
简要总结
Prospective, non-comparative, multi-centre, multi-country, observational post-authorization study, to correlate predictive factors with number of oocytes in relation to the gonadotropin dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation and GnRH-antagonists for pituitary suppression
详细描述
This will be a prospective, non-comparative, multi-centre, multi-country, observational post-authorization study in Germany and Austria. The study will evaluate the use of follitropin alfa (Bemfola®) in controlled ovarian stimulation for IVF/ICSI.
About 30 ART centres will be involved in the study. Upon site initiation, each investigator site will enrol the subjects who meet the inclusion criteria.
As this is an observational study, there will be no additional treatment or diagnostic procedures performed on subjects other than those of the investigators' local routine clinical practice. The decision to start ART treatment and to use Bemfola® in controlled ovarian hyperstimulation (COH) following a GnRH antagonist protocol will be made independently by the investigators as per the ART centre's protocol, preceding patient enrollment for this study.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subject justifying an IVF/ICSI treatment
- •Age over 18 years (inclusive) at the time of the screening visit
- •Signed informed patient consent
- •Received only Bemfola® for ovarian stimulation
- •Pituitary suppression with GnRH-antagonists
排除标准
- •Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients
- •Tumours of the hypothalamus or pituitary gland
- •Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
- •Gynaecological haemorrhages of unknown aetiology
- •Ovarian, uterine or mammary carcinoma
结局指标
主要结局
Number of oocytes retrieved
时间窗: 34-36 hours after hCG administration
次要结局
- Basal FSH level(Day 1)
- r-hFSH dose on first and last day of stimulation(Day 1 of stimulation through to maximum Day 16 of stimulation)
- Days of FSH stimulation (with r-hFSH daily doses)(Day 1 of stimulation through to maximum Day 16 of stimulation)
- Number of embryos transferred(Day 2-5 after ovum pick-up)
- Antral Follicle Count (AFC)(Day 1)
- r-hFSH total dose(Day 1 of stimulation through to maximum Day 16 of stimulation)
- Number of oocytes fertilized (classified as 2PN stages)(Day 1,2,3 or 5 after ovum pick-up/fertilisation)
- Proportion of Biochemical pregnancies (determined by serum B-hCG levels)(15-20 days after oocyte retrieval)
- Proportion of clinical pregnancies (determined by the presence of a gestational sac)(35-42 days after oocyte retrieval)
- Type of oocyte trigger (ß-hCG / GnRH agonist)(At Day of hCG administration)
- Number of 2PN cells cryopreserved(Day 1,2,3 or 5 after ovum pick-up/fertilisation)
- Implantation rate (gestational sacs with heartbeat per total number of embryos transferred)(15-20 days after oocyte retrieval)
- Incidence of Ovarian Hyper-Stimulation Syndrome (OHSS), classified as mild, moderate and severe(From Day 1 of stimulation)
- Incidence of ALL other Treatment-Emergent Adverse Events(From Day 1 of study period)