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临床试验/NCT04773353
NCT04773353已完成3 期

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial in India Comparing the Efficacy and Safety of FE 999049 (Follitropin Delta) With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

Ferring Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2021年12月3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
220
试验地点
1
主要终点
Ongoing pregnancy rate
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

To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women 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
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 40 Years（Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •Informed Consent Forms signed prior to screening evaluations.
  • •In good physical and mental health as judged by the investigator.
  • •Indian (i.e., possessing an Indian identification card and having native Indian parents) pre-menopausal females between the ages of 21 and 40 years. The participants must be at least 21 years (including the 21st birthday) when they sign the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomization.
  • •Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II (defined by the revised American Society for Reproductive Medicine [ASRM] classification, 1996) or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (IVF) and/or ICSI using fresh or frozen ejaculated sperm from male partner or sperm donor.
  • •Infertility for at least one year before randomization for participants <35 years or for at least 6 months for participants ≥35 years (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.
  • •Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
  • •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 randomization.
  • •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) within 1 year prior to randomization. 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 within 1 year prior to randomization.
  • •Body mass index (BMI) between 17.5 and 32.0 kg/m^2 (both inclusive) at screening.
  • •Willing to accept transfer of 1-2 embryos.

排除标准

  • •Known endometriosis stage III-IV (defined by the revised ASRM classification, 1996).
  • •One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound prior to randomization on stimulation day 1 (puncture of cysts is allowed prior to randomization).
  • •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.
  • •Any known clinically significant systemic disease (e.g., insulin-dependent diabetes).
  • •Known inherited or acquired thrombophilia disease.
  • •Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
  • •Known porphyria.
  • •Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled thyroid function disease.
  • •Known presence of anti-FSH antibodies (based on the information available in the participant's medical records).
  • •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, haematology or vital signs at screening which is clinically significant as judged by the investigator.
  • •Currently breast-feeding.
  • •Undiagnosed vaginal bleeding.
  • •Known abnormal cervical cytology of clinical significance observed within 3 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.
  • •Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle before randomization.
  • •Known history of chemotherapy (except for gestational conditions) or radiotherapy.
  • •Current or past (1 year prior to randomization) abuse of alcohol or drugs.
  • •Current (last month) intake of more than 14 units of alcohol per week.
  • •Current or past (3 months prior to randomization) smoking habit of more than 10 cigarettes per day.
  • •Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial.
  • •Previous participation in the trial.
  • •Use of any non-registered investigational drugs during the last 3 months prior to randomization.

研究组 & 干预措施

Follitropin Delta (FE 999049)

Experimental

Recombinant follicle-stimulating hormone (rFSH). Follitropin delta for subcutaneous injection

干预措施: Follitropin Delta (FE 999049) (Drug)

Follitropin Alfa (GONAL-F)

Experimental

rFSH. Follitropin alfa for subcutaneous injection

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 embryo transfer

Ongoing pregnancy is defined as at least one intrauterine viable fetus 10-11 weeks after embryo transfer.

次要结局

  • Vital pregnancy rate(5-6 weeks after embryo transfer)
  • Positive beta human chorionic gonadotropin (βhCG) rate(13-15 days after embryo transfer)
  • Clinical pregnancy rate(5-6 weeks after embryo transfer)
  • Implantation rate(5-6 weeks after embryo transfer)
  • Ongoing implantation rate(10-11 weeks after embryo transfer)
  • Proportion of subjects with extreme ovarian responses(On day of oocyte retrieval (up to 22 days after start of stimulation))
  • Proportion of subjects with early ovarian hyperstimulation syndrome (OHSS) (including OHSS of moderate/severe grade) and/or preventive interventions for early OHSS(≤9 days after triggering of final follicular maturation)
  • Proportion of subjects with cycle cancellation due to poor or excessive ovarian response or embryo transfer cancellation due to excessive ovarian response / OHSS risk(At end-of-stimulation (up to 20 stimulation days) or transfer visit)
  • Number of follicles on stimulation Day 6(On stimulation Day 6)
  • Number of follicles at end-of-stimulation(At end-of-stimulation (up to 20 stimulation days))
  • Size of follicles on stimulation Day 6(On stimulation Day 6)
  • 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))
  • Percentage of metaphase II oocytes (only applicable for those inseminated using intracytoplasmic sperm injection [ICSI])(On day of oocyte retrieval (up to 22 days after stimulation))
  • Fertilisation rate(On Day 1 after oocyte retrieval (up to 23 days after start of stimulation))
  • Number and quality of embryos on day 3 after oocyte retrieval(On Day 3 after oocyte retrieval (up to 25 days after start of stimulation))
  • Circulating concentrations of follicle-stimulating hormone (FSH) and luteinizing hormone (LH)(On stimulation day 6)
  • Circulating concentrations of estradiol(At end-of-stimulation (up to 20 stimulation days))
  • Circulating concentrations of progesterone(At end-of-stimulation (up to 20 stimulation days))
  • Circulating concentrations of inhibin A and inhibin B(At end-of-stimulation (up to 20 stimulation days))
  • Circulating concentrations of FSH and LH(At end-of-stimulation (up to 20 stimulation days))
  • Total gonadotropin dose(At end-of-stimulation (up to 20 stimulation days))
  • Number of stimulation days(At end-of-stimulation (up to 20 stimulation days))
  • Proportion of subjects with investigator-requested gonadotropin dose adjustments(From stimulation Day 6 to end-of-stimulation (up to 20 stimulation days))
  • Number of events and intensity of adverse events(From signing of the informed consent up to end-of-trial (approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical chemistry parameters: Albumin and Total protein(From screening up to end-of-trial (up to approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical chemistry parameters: Alanine transaminase, Alkaline phosphatase, Aspartate aminotransferase, Gamma-glutamyl transpeptidase(From screening up to end-of-trial (up to approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical chemistry parameters: Bicarbonate, Blood urea nitrogen, Calcium, Chloride, Cholesterol total, Glucose, Phosphorus, Potassium, Sodium, Uric acid(From screening up to end-of-trial (up to approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical chemistry parameters: Bilirubin direct, Bilirubin, Creatinine(From screening up to end-of-trial (up to approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical chemistry parameters: Lactate dehydrogenase(From screening up to end-of-trial (up to approximately 5.5 months))
  • Proportion of subjects with markedly abnormal changes from baseline in clinical chemistry at end-of-stimulation(At end-of-stimulation (up to 20 stimulation days))
  • Proportion of subjects with markedly abnormal changes from baseline in clinical chemistry at end-of-trial(At end-of-trial (up to approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical haematology parameters: Red blood cells, Red blood cells morphology(From screening up to end-of-trial (up to approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical haematology parameters: White blood cells, White blood cell morphology, Platelets(From screening up to end-of-trial (up to approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical haematology parameters: Haemoglobin(From screening up to end-of-trial (up to approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical haematology parameters: Haematocrit(From screening up to end-of-trial (up to approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical haematology parameters: Mean Corpuscular Volume(From screening up to end-of-trial (up to approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical haematology parameters: Mean Corpuscular Haemoglobin(From screening up to end-of-trial (up to approximately 5.5 months))
  • Changes from baseline in circulating levels of clinical haematology parameters: Mean Corpuscular Hemoglobin Concentration(From screening up to end-of-trial (up to approximately 5.5 months))
  • Proportion of subjects with markedly abnormal changes from baseline in haematology parameters at end-of-stimulation(At end-of-stimulation (up to 20 stimulation days))
  • Proportion of subjects with markedly abnormal changes from baseline in haematology parameters end-of-trial(At end-of-trial (up to approximately 5.5 months))
  • Frequency of injection site reactions (redness, pain, itching, swelling and bruising)(At end-of-stimulation (up to 20 stimulation days))
  • Intensity of injection site reactions(At end-of-stimulation (up to 20 stimulation days))
  • Frequency of immune-related adverse events(From signing of the informed consent up to end-of-trial (approximately 5.5 months))
  • Intensity of immune-related adverse events(From signing of the informed consent up to end-of-trial (approximately 5.5 months))
  • Proportion of subjects with cycle cancellations due to an adverse event, including immune-related adverse events, or due to technical malfunctions of the pre-filled injection pen(At end-of-stimulation (up to 20 stimulation days))
  • Proportion of subjects with late OHSS (including OHSS of moderate/severe grade)(>9 days after triggering of final follicular maturation)
  • Proportion of subjects with OHSS (early and/or late) and/or preventive interventions for early OHSS(>9 days after triggering of final follicular maturation)
  • Percentage of subjects with multi-fetal gestation, biochemical pregnancy, spontaneous abortion, ectopic pregnancy (with and without medical/surgical intervention) and vanishing twins(10-11 weeks after transfer)
  • Technical malfunctions of the pre-filled injection pen(At end-of-stimulation (up to 20 stimulation days))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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