NCT01956110已完成3 期
A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,329
- 试验地点
- 13
- 主要终点
- Ongoing Pregnancy Rate
研究概览
简要总结
This trial investigates the effects of FE 999049 compared to GONAL-F.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed Consent Documents signed prior to screening evaluations
- •In good physical and mental health
- •Pre-menopausal females between the ages of 18 and 40 years
- •Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor
- •Infertility for at least one year before randomisation for subjects ≤37 years or for at least 6 months for subjects ≥38 years (not applicable in case of tubal or severe male factor infertility)
- •The trial cycle will be the subject's first controlled ovarian stimulation cycle for IVF/ICSI
- •Hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to randomisation
- •Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm or enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomisation. Both ovaries must be accessible for oocyte retrieval.
- •Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomisation)
- •Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening
排除标准
- •Known endometriosis stage III-IV
- •One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to randomisation on stimulation day 1
- •Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy)
- •Known abnormal karyotype of subject or of her partner/sperm donor, as applicable, depending on source of sperm used for insemination in this trial.
- •Any known clinically significant systemic disease (e.g. insulin-dependent diabetes)
- •Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease
- •Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
研究组 & 干预措施
A
Experimental
Follitropin Delta (FE 999049)
干预措施: Follitropin Delta (FE 999049) (Drug)
B
Active Comparator
Follitropin Alfa (GONAL-F)
干预措施: Follitropin Alfa (GONAL-F) (Drug)
结局指标
主要结局
Ongoing Pregnancy Rate
时间窗: 10-11 weeks after blastocyst transfer
Ongoing pregnancy was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer.
Ongoing Implantation Rate
时间窗: 10-11 weeks after blastocyst transfer
Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred.
次要结局
- Vital Pregnancy Rate(5-6 weeks after blastocyst transfer)
- Implantation Rate(5-6 weeks after blastocyst transfer)
- Proportion of Subjects With Extreme Ovarian Responses, Defined as <4, ≥15 or ≥20 Oocytes Retrieved(Day of oocyte retrieval)
- Proportion of Subjects With Early OHSS (Ovarian Hyperstimulation Syndrome) and/or Preventive Interventions for Early OHSS(≤9 days after triggering of final follicular maturation)
- Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response(End-of-stimulation (up to 20 stimulation days))
- Number of Oocytes Retrieved(Day of oocyte retrieval)
- Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved(Day of oocyte retrieval)
- Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments(End-of-stimulation (up to 20 stimulation days))
- Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period(End-of-stimulation (up to 20 stimulation days))
- Number of Stimulation Days(End-of-stimulation (up to 20 stimulation days))
- Abdominal Discomfort Related to Controlled Ovarian Stimulation as Assessed by a Visual Analogue Scale (VAS)(End-of-stimulation and day of blastocyst transfer)
- Changes in Body Weight(End-of-stimulation and day of blastocyst transfer)
- Changes in Maximum Abdominal Circumference(End-of-stimulation and day of blastocyst transfer)
- Proportion of Subjects With Treatment-induced Anti-follicle-stimulating Hormone (FSH) Antibodies(Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose)
- Proportion of Subjects With Late OHSS(>9 days after triggering of final follicular maturation)
- Technical Malfunctions of the Administration Pen(End-of-stimulation (up to 20 stimulation days))
- Percentage of Metaphase II Oocytes (Oocytes Inseminated Using ICSI [Intracytoplasmic Sperm Injection])(Prior to insemination)
- Fertilisation Rate(Day 1 after insemination)
- Number and Quality of Embryos on Day 3(On day 3 after oocyte retrieval)
- Number and Quality of Blastocysts on Day 5(On day 5 after oocyte retrieval)
- Total Gonadotropin Dose(End-of-stimulation (up to 20 stimulation days))
研究者
研究点 (13)
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