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临床试验/NCT03738618
NCT03738618已完成3 期

A Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Trial Investigating the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Women Aged 35-42 Years Undergoing Assisted Reproductive Technology

Ferring Pharmaceuticals24 个研究点 分布在 1 个国家目标入组 588 人开始时间: 2018年10月29日最近更新:
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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
588
试验地点
24
主要终点
Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of Controlled Ovarian Stimulation (COS)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial investigates the effects of FE 999049 compared to placebo.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 42 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 procedure.
  • •In good physical and mental health in the judgement of the investigator.
  • •Pre-menopausal women between the ages of 35 and 42 years. The participants must be at least 35 years (including the 35th birthday) when they sign the informed consent and no more than 42 years (up to the day before the 42nd birthday) at the time of randomization.
  • •Body mass index (BMI) between 17.5 and 38.0 kg/m^2 (both inclusive) at screening.
  • •Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
  • •Documented history of infertility for at least 6 months before randomization (not applicable in case of tubal or severe male factor infertility, or when the use of donor sperm is indicated).
  • •Regular menstrual cycles of 24-35 days (both inclusive).
  • •Hysterosalpingography, hysteroscopy or saline infusion sonography, documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous fibroids of any size 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) at screening or within 1 year prior to screening.
  • •Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of significant abnormality (e.g. enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) at screening. 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 randomization).
  • •Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests at screening or within 6 months prior to screening.
  • •Willing to accept the blastocyst transfer policy for the fresh cycle and the cryopreserved cycles initiated within 12 months from the start of controlled ovarian stimulation using blastocysts obtained in this trial, i.e. transfer of one blastocyst (if a good-quality blastocyst is available) or transfer of one or two blastocysts (if no good-quality blastocyst is available).

排除标准

  • •More than one previous controlled ovarian stimulation cycle for IVF/ICSI.
  • •Known endometriosis stage III-IV (defined by the revised ASRM classification, 2012).
  • •Known history of anovulation.
  • •One or more follicles greater than or equal to 10 mm (including cysts) observed on the transvaginal ultrasound prior to randomization on stimulation day
  • •Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24 of pregnancy).
  • •Known abnormal karyotype of participant or of her partner / sperm donor, as applicable, depending on source of sperm used for insemination in this trial. In case partner sperm will be used and the sperm production is severely impaired (concentration less than 1 million/mL), normal karyotype, including no Y-chromosome microdeletion, must be documented.
  • •Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
  • •Known inherited or acquired thrombophilia.
  • •Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
  • •Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of pharmacologically controlled sub-clinical hypothyroidism.
  • •Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
  • •Known moderate or severe impairment of renal or hepatic function.
  • •Any abnormal finding of clinical chemistry, hematology, thyroid-stimulating hormone (TSH) or prolactin, or vital signs at screening, which is judged clinically significant by the investigator.
  • •Known abnormal cervical cytology of clinical significance observed within three years prior to randomization (unless the clinical significance has been resolved).
  • •Findings at the gynecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device.
  • •Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to randomization) or contraindication to pregnancy.
  • •Known current active pelvic inflammatory disease.
  • •Use of fertility modifiers during the last menstrual cycle before randomization, including dehydroepiandrosterone (DHEA), metformin or cycle programming with oral contraceptives, progestogen or estrogen preparations.

研究组 & 干预措施

FE 999049 (Follitropin Delta)

Experimental

干预措施: Follitropin delta (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of Controlled Ovarian Stimulation (COS)

时间窗: 8-9 weeks after transfer (up to approximately 16 months after start of stimulation)

Defined as at least one intrauterine viable fetus 8-9 weeks after transfer. Data in this endpoint are presented for the fresh cycle and the cryopreserved cycles.

次要结局

  • Ongoing Pregnancy Rate in the Fresh Cycle and in the Cryopreserved Cycles(8-9 weeks after transfer (up to approximately 16 months after start of stimulation))
  • Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Including Duration(8-9 weeks after transfer (up to approximately 16 months after start of stimulation))
  • Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Measured in Number of Cycles Before Achieving Ongoing Pregnancy(8-9 weeks after transfer (up to approximately 16 months after start of stimulation))
  • Ongoing Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively(8-9 weeks after transfer (up to approximately 16 months after start of stimulation))
  • Clinical Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively(5-6 weeks after transfer (up to approximately 15 months after start of stimulation))
  • Number of Follicles on Stimulation Day 5(On stimulation day 5)
  • Number of Follicles at End-of-stimulation(At end-of-stimulation (up to 20 stimulation days))
  • Size of Follicles on Stimulation Day 5(On stimulation day 5)
  • Size of Follicles at End-of-stimulation(At end-of-stimulation (up to 20 stimulation days))
  • Number of Oocytes Retrieved(On day of oocyte retrieval (up to 22 days after start of stimulation))
  • Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved(On day of oocyte retrieval (up to 22 days after start of stimulation))
  • Number of Metaphase II Oocytes(On day of oocyte retrieval (up to 22 days after start of stimulation))
  • Number of Fertilized Oocytes(On day 1 after oocyte retrieval (up to 23 days after start of stimulation))
  • Fertilization Rate(On day 1 after oocyte retrieval (up to 23 days after start of stimulation))
  • Vital Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively(5-6 weeks after transfer (up to approximately 15 months after start of stimulation))
  • Positive Beta Human Chorionic Gonadotropin (βhCG) Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively(10-14 days after transfer (up to approximately 14 months after start of stimulation))
  • Proportion of Subjects in the Fresh Cycle With Triggering of Final Follicular Maturation (With hCG, With GnRH Agonist, and in Total), Cycle Cancellation and Transfer Cancellation(Up to 5 days after oocyte retrieval (up to 27 days after start of stimulation))
  • Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively(5-6 weeks after transfer (up to approximately 15 months after start of stimulation))
  • Circulating Concentrations of Inhibin A(From screening to the day of oocyte retrieval (up to 22 days after start of stimulation))
  • Circulating Concentrations of Inhibin B(From screening to the day of oocyte retrieval (up to 22 days after start of stimulation))
  • Total Gonadotropin Dose(Up to 20 stimulation days)
  • Proportion of Participants With Investigator-requested Gonadotropin Dose Adjustments(Stimulation Day 5)
  • Proportion of Subjects Hospitalized Due to OHSS and Proportion of Subjects Undergoing Paracentesis Due to OHSS(≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS))
  • Proportion of Cryopreserved Cycles With Multi-fetal Gestation(Up to 8-9 weeks after transfer)
  • Number and Quality of Blastocysts on Day 5 After Oocyte Retrieval(On day 5 after oocyte retrieval)
  • Endometrial Thickness on Stimulation Day 5(On stimulation day 5)
  • Endometrial Thickness at End-of-stimulation(At end-of-stimulation (up to 20 stimulation days))
  • Echogenicity Pattern on Stimulation Day 5(On stimulation day 5)
  • Echogenicity Pattern at End-of-stimulation(At end-of-stimulation (up to 20 stimulation days))
  • Oocyte Utilization Rate(On day of oocyte retrieval up to 12 months after start of COS)
  • Percentage of Blastocysts Surviving Cryopreservation(0 hour (+0.5 hour) after thawing)
  • Percentage of Blastocysts With Re-expansion After Cryopreservation(2.5 hour (±0.5 hour) after thawing)
  • Number of Cryopreserved Cycles Initiated Within 12 Months From the Start of COS(Up to 12 months after start of stimulation)
  • Number of Cryopreserved Cycles With Blastocyst Transfer(Up to 12 months after start of stimulation)
  • Circulating Concentrations of Anti-mullerian Hormone (AMH)(From screening to the day of oocyte retrieval (up to 22 days after start of stimulation))
  • Circulating Concentrations of Follicle-stimulating Hormone (FSH)(From screening to the day of oocyte retrieval (up to 22 days after start of stimulation))
  • Circulating Concentrations of Luteinizing Hormone (LH)(From screening to the day of oocyte retrieval (up to 22 days after start of stimulation))
  • Circulating Concentrations of Estradiol(From screening to the day of oocyte retrieval (up to 22 days after start of stimulation))
  • Circulating Concentrations of Progesterone(From screening to the day of oocyte retrieval (up to 22 days after start of stimulation))
  • Oocyte Efficiency Index(8-9 weeks after transfer)
  • Number of Stimulation Days(Up to 20 stimulation days)
  • Percentage of Participants With Adverse Events (AEs)(From time of signing informed consent until the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Direct Bilirubin, Total Bilirubin, Creatinine, Urate(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Lactate Dehydrogenase(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Changes in Haematology Parameters Compared to Baseline: Erythrocytes(From screening to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Intensity of AEs(From time of signing informed consent until the end-of-cycle visit in the fresh cycle (up to approximately 6 months))
  • Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Albumin, Protein(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Changes in Haematology Parameters Compared to Baseline: Haematocrit(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Changes in Haematology Parameters Compared to Baseline: Leukocytes and Platelets(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Changes in Haematology Parameters Compared to Baseline: Haemoglobin(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Changes in Haematology Parameters Compared to Baseline: Erythrocyte Mean Corpuscular Volume(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Changes in Haematology Parameters Compared to Baseline: Erythrocyte Mean Corpuscular Hemoglobin(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Changes in Haematology Parameters Compared to Baseline: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry Parameters: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Potassium(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes(From screening (baseline) to the end-of-stimulation visit and end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Frequency and Intensity 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))
  • Intensity 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))
  • Changes in Haematology Parameters Compared to Baseline: Erythrocyte Mean Corpuscular Haemoglobin Concentration(From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Frequency and Intensity of Immune-related Adverse Events(From time of signing informed consent for participation in the trial until the end-of-cycle visit in the fresh cycle (approximately 6 months))
  • Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity(Up to 28 days after end of the stimulation period)
  • Proportion of Participants With Multi-fetal Gestation in the Fresh Cycle(Up to 8-9 weeks after transfer)
  • Biochemical Pregnancy, Spontaneous Abortion, Ectopic Pregnancy (With and Without Medical/Surgical Intervention) and Vanishing Twins in the Cryopreserved Cycles(Up to 8-9 weeks after transfer)
  • Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen(Up to 20 stimulation days)
  • Proportion of Subjects With OHSS, Overall and by Grade, and Proportion of Subjects With Moderate/Severe OHSS(≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS))
  • Biochemical Pregnancy, Spontaneous Abortion, Ectopic Pregnancy (With and Without Medical/Surgical Intervention) and Vanishing Twins in the Fresh Cycle(Up to 8-9 weeks after transfer)
  • Proportion of Participants With Technical Malfunctions of the Administration Pen(Up to 20 stimulation days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (24)

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