NCT03228680已完成3 期
A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese 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
- 373
- 试验地点
- 17
- 主要终点
- Number of Oocytes Retrieved
研究概览
简要总结
To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 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 any trial-related procedures.
- •In good physical and mental health.
- •Japanese females between the ages of 20 and 40 years.
- •Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II (defined by the revised American Society for Reproductive Medicine (ASRM) classification) or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) treatment using ejaculated sperm from male partner.
- •Infertility for at least 1 year before randomization (not applicable in case of tubal or severe male factor infertility).
- •The trial cycle will be the participant'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 screening. This also includes women who have been diagnosed with any of the above medical conditions but have had them surgically corrected within 1 year prior to screening.
- •Transvaginal ultrasound documenting presence and adequate visualization 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 fallopian tubes and surrounding tissue without evidence of significant abnormality (e.g. no hydrosalpinx) within 1 year prior to screening. Both ovaries must be accessible for oocyte retrieval.
- •Early follicular phase (cycle day 2-4) serum levels of follicle stimulating hormone (FSH) between 1 and 15 IU/L (results obtained within 3 months prior to screening).
- •Body mass index (BMI) between 17.5 and 32.0 kg/m^2 (both inclusive) at screening.
排除标准
- •Known endometriosis stage III-IV (defined by the revised ASRM classification).
- •One or more follicles >10 mm (including cysts) observed on the transvaginal ultrasound prior to start of stimulation on stimulation day 1 (puncture of cysts prior randomization is allowed).
- •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 participant or of her partner. In case the sperm production is severely impaired (concentration <1 million/mL), normal karyotype, including no Y chromosome microdeletion, must be documented.
- •Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
- •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
Follitropin delta
Experimental
FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
干预措施: Follitropin delta (Drug)
Follitropin beta
Active Comparator
FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days.
干预措施: Follitropin beta (Drug)
结局指标
主要结局
Number of Oocytes Retrieved
时间窗: 36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval)
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
次要结局
- Clinical Pregnancy Rate(5-6 weeks after transfer (up to approximately 3 months after start of stimulation))
- Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate(13-15 days after transfer (up to approximately 1.5 months after start of stimulation))
- Vital Pregnancy Rate(5-6 weeks after transfer (up to approximately 3 months after start of stimulation))
- Implantation Rate(5-6 weeks after transfer (up to approximately 3 months after start of stimulation))
- Proportion of Participants With Cycle Cancellation Due to Poor or Excessive Ovarian Response(End-of-stimulation (up to 20 stimulation days))
- Proportion of Participants With Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk(End-of-stimulation (up to 20 stimulation days))
- Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved(On the day of oocyte retrieval (up to 22 days after start of stimulation))
- Proportion of Participants With Extreme Ovarian Responses (Defined as <4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population(On the day of oocyte retrieval (up to 22 days after start of stimulation))
- Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS)(≤9 days after triggering of final follicular maturation)
- Proportions of Participants With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS(Up to 9 days after triggering of final follicular maturation)
- Proportions of Participants With Late OHSS (Including OHSS of Moderate/Severe Grade)(>9 days after triggering of final follicular maturation)
- Number of Follicles on Stimulation Day 6(At Day 6 of stimulation)
- Number of Follicles at End-of-stimulation(End-of-stimulation (up to 20 stimulation days))
- Size of Follicles on Stimulation Day 6(At Day 6 of stimulation)
- Size of Follicles at End-of-Stimulation(End-of-stimulation (up to 20 stimulation days))
- Fertilization Rate(Day 1 after oocyte retrieval (up to approximately 22 days after start of stimulation))
- Circulating Levels of Endocrine Parameters (Inhibin B) at End-of-stimulation(End-of-stimulation (up to 20 stimulation days))
- Number and Quality of Embryos(Day 3 after oocyte retrieval (up to approximately 24 days after start of stimulation))
- Number and Quality of Blastocysts(Day 5 after oocyte retrieval (up to approximately 26 days after start of stimulation))
- Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) on Stimulation Day 6(At Day 6 of stimulation)
- Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) at End-of-stimulation(End-of-stimulation (up to 20 stimulation days))
- Circulating Levels of Endocrine Parameter (Estradiol) on Stimulation Day 6(At Day 6 of stimulation)
- Circulating Levels of Endocrine Parameter (Estradiol) at End-of-stimulation(End-of-stimulation (up to 20 stimulation days))
- Circulating Levels of Endocrine Parameter (Progesterone) on Stimulation Day 6(At Day 6 of stimulation)
- Circulating Levels of Endocrine Parameter (Progesterone) at End-of-stimulation(End-of-stimulation (up to 20 stimulation days))
- Circulating Levels of Endocrine Parameters (Inhibin A) on Stimulation Day 6(At Day 6 of stimulation)
- Circulating Levels of Endocrine Parameters (Inhibin A) at End-of-stimulation(End-of-stimulation (up to 20 stimulation days))
- Circulating Levels of Endocrine Parameters (Inhibin B) on Stimulation Day 6(At Day 6 of stimulation)
- Number of Stimulation Days(End-of-stimulation (up to 20 stimulation days))
- Total Gonadotropin Dose of FE 999049(End-of-stimulation (up to 20 stimulation days))
- Total Gonadotropin Dose of FOLLISTIM(End-of-stimulation (up to 20 stimulation days))
- Number of Participants With Adverse Events (AEs) Stratified by Intensity(From signed informed consent up to 5-6 weeks after transfer)
- Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-stimulation(End-of-stimulation (up to 20 stimulation days))
- Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-stimulation(End-of-stimulation (up to 20 stimulation days))
- Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-trial(Up to 5-6 weeks after transfer)
- Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-trial(Up to 5-6 weeks after transfer)
- Frequency and Intensity of Injection Site Reactions(End-of-stimulation (up to 20 stimulation days))
- Technical Malfunctions of the Administration Pens(End-of-stimulation (up to 20 stimulation days))
研究者
研究点 (17)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian WomenInfertilityNCT04773353Ferring Pharmaceuticals220
已完成
3 期
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian WomenControlled Ovarian SimulationNCT03296527Ferring Pharmaceuticals1,011
已完成
3 期
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1InfertilityNCT01956110Ferring Pharmaceuticals1,329
已完成
2 期
A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI TreatmentInfertilityNCT01426386Ferring Pharmaceuticals265
已完成
3 期
Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-1)InfertilityNCT03740737Ferring Pharmaceuticals579