NCT01121666已完成3 期
A Phase III Assessor-blinded Randomized Parallel Group Multi-centre Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA Versus Gonal-f) in Women for Assisted Reproductive Treatment
Finox AG16 个研究点 分布在 6 个国家目标入组 460 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 460
- 试验地点
- 16
- 主要终点
- Number of Oocytes Retrieved (Per Protocol Population)
研究概览
简要总结
Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 38 years with regular menstrual cycles of 25-35 days
- •First or second cycle in the present series of ART
- •BMI ≥ 18 ≤ 30 kg/m2
- •Basal FSH < 10 IU/L (cycle day 2-5)
- •E2 levels < 50pg/mL (< 0.18 nmol/L) at the day of FSH administration
- •Antral follicle count (AFC) ≥ 10 to ≤ 25 follicles (sum of both ovaries)
- •Infertility due to any of the following factors: tubal factor, mild endometriosis (ASRM stage 1-2), male factor, unexplained infertility
- •Presence of both ovaries and normal uterine cavity (confirmed by transvaginal ultrasound within 6 months before randomisation)
- •Willingness to participate in the study and to comply with the study protocol
- •Informed consent
排除标准
- •Presence of pregnancy
- •History of ≥2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy
- •Presence of clinically significant systemic disease
- •Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
- •Presence of uncontrolled endocrine disorder
- •Previous history or presence of severe ovarian hyperstimulation syndrome
- •Presence of polycystic ovaries (PCO)
- •Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx
- •Neoplasia, including tumors of the hypothalamus and pituitary gland
- •Abnormal bleeding of undetermined origin
- •History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)
- •Male infertility without mobile spermatozoa in the ejaculate, that need testicular of epididymal sperm retrieval (MESA/TESE/TESA)
- •Endocrine abnormality such as TSH or prolactin level elevations outside the reference range if clinically relevant at screening
- •Any hormonal treatment within 1 month before the start of the FSH treatment (with the exception of levothyroxin)
- •History of drug, nicotine or alcohol abuse within the last 12 months (> 10 cigarettes/day)
- •Administration of other investigational products within the last month
- •Clinically abnormal findings at Visit 1
- •Planned PGS/PGD/PBB or assisted hatching
- •Concomitant participation in an other study protocol
- •History of extrauterine pregnancy in the previous 3 months
- •Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medication (GnRH agonist, vitrelle®, and Utrogestan®)
- •Presence or history of thrombophlebitis or thromboembolic disorders
- •Presence or history of cerebral haemorrhage
- •Presence or history of porphyria
研究组 & 干预措施
Gonal-f® (Follitropin alfa)
Active Comparator
干预措施: Follitropin alfa (Drug)
AFOLIA-150 (Follitropin alfa)
Experimental
干预措施: Follitropin alfa (Drug)
结局指标
主要结局
Number of Oocytes Retrieved (Per Protocol Population)
时间窗: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
Number of Oocytes Retrieved (Intention-to-treat Population)
时间窗: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment
As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes
次要结局
- Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation(Day 8 of stimulation)
- E2 Concentration at Day 8 and at Day of hCG Administration(Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment))
- Total Dose of r-hFSH Administered(Day of hCG administration (after maximum 16 days of r-hFSH treatment))
- Quality of Oocytes Retrieved(After oocyte retrieval, 34 to 36 hours after hCG administration)
- Fertilisation Rate of Oocytes(1 day after ovum pick-up)
- Embryo Quality: Mean Number of Blastomeres(Day 2 of OPU/fertilisation)
- Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts(Day 1, 2, 3 and 5 of OPU/fertilisation)
- Number of Days of r-hFSH Stimulation(At the day of hCG administration, up to 16 days)
- Number of Patients With Cycle Cancellation(Until child birth/miscarriage, up to the end of the study)
- Number of Patients With Good Response(Until child birth/miscarriage, up to the end of the study)
- Implantation Rate(Five to six weeks after oocyte retrieval)
- Clinical Pregnancy Rate(Five to six weeks after oocyte retrieval)
- Ongoing Pregnancy(Ten weeks after embryo transfer)
- Live Birth Rate(After childbirth with questionnaire)
- Embryo Quality: Absence of Multinucleation(Day 3)
- Clinical Pregnancy Rate (Second Treatment Cycle)(Five to six weeks after oocyte retrieval)
- Ongoing Pregnancy (Second Treatment Cycle)(10 weeks after embryo transfer)
研究者
研究点 (16)
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