NCT04163458已完成3 期
A Randomized, Double-blind Double-dummy Trial Comparing MENOPUR Solution for Injection in a Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection (Menotropins for Injection) in a GnRH Agonist Cycle in Women Aged 18-42 Years Undergoing an Assisted Reproductive Technology Program
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
- 405
- 试验地点
- 20
- 主要终点
- Number of Fertilized (2 Pronuclei [2PN]) Oocytes
研究概览
简要总结
Development of multiple follicles and pregnancy in ovulatory women undergoing controlled ovarian stimulation as part of an assisted reproductive technology (ART) cycle.
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
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consents, prior to any trial-related procedure.
- •Females between the ages of 18 and 42 years. The participants must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 42 years (up to the day before the 43rd birthday) at the time of randomization who desire pregnancy.
- •Body mass index (BMI) between 17.5 and 38.0 kg/m^2 (both inclusive) at screening.
- •Regular menstrual cycles of 24 to 35 days, presumed to be ovulatory.
- •Documented history of infertility for at least 12 months before randomization for women ≤35 years or for at least 6 months for women ≥36 years. Women with documented bilateral tubal occlusion or male factor infertility requiring the use of donor sperm established as a cause of infertility are eligible at diagnosis.
- •Early follicular phase (cycle day 2-4) serum FSH level between 1 and 12 IU/L (results obtained within 3 months prior to randomization).
- •Male partner with semen analysis that is at least adequate for intracytoplasmic sperm injection (ICSI) at screening or within 6 months prior to the screening date. Partners with severe male factors requiring invasive or surgical sperm retrieval may not be used. Use of donor sperm is allowed.
- •At least 1 cycle with no fertility medication immediately prior to screening.
- •Hysterosalpingography, hysteroscopy, or saline hysterosonogram documenting uterine anatomy appropriate for ART at screening or within 12 months prior to screening.
- •Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of clinically significant abnormality (e.g., endometrioma ≥3 cm, no dermoid cysts) and normal adnexa (e.g., no hydrosalpinx) at screening. Both ovaries must be accessible for oocyte retrieval.
排除标准
- •More than two previous controlled ovarian stimulation cycles for in vitro fertilization (IVF)/ICSI
- •Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).
- •Oocyte donor or embryo recipient; gestational or surrogate carrier.
- •Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24 of pregnancy).
- •Participant's male partner, with obvious leukospermia (>2 million white blood cells/mL) or signs of infection in semen sample within 6 months of the participant's screening. If either of these conditions exists, the male should be treated with antibiotics and retested prior to the participant's randomization.
- •Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
- •Any known endocrine (total testosterone, prolactin and TSH) or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled thyroid function disease.
- •Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotrophins.
- •Any abnormal finding of clinical chemistry, hematology and vital signs at screening, which is judged clinically significant by the investigator.
- •Pregnancy (negative urine pregnancy test must be documented at screening and prior to the first investigational medicinal product [IMP] administration), or contraindication to pregnancy.
- •Hypersensitivity to any active ingredient or excipients in the medicinal products used in this trial.
研究组 & 干预措施
MENOPUR liquid
Experimental
MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.
干预措施: MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL (Drug)
MENOPUR liquid
Experimental
MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.
干预措施: Placebo (for MENOPUR powder and solvent for solution for injection) (Other)
MENOPUR powder
Active Comparator
MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.
干预措施: MENOPUR powder and solvent for solution for injection, 75 IU (Drug)
MENOPUR powder
Active Comparator
MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.
干预措施: Placebo (for MENOPUR solution for injection in pre-filled pen) (Other)
结局指标
主要结局
Number of Fertilized (2 Pronuclei [2PN]) Oocytes
时间窗: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Fertilized oocytes with 2PN were regarded as correctly fertilized.
次要结局
- Positive Beta Human Chorionic Gonadotropin (βhCG) Rate(10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation))
- Clinical Pregnancy Rate(5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation))
- Follicular Development on Stimulation Day 6(At stimulation Day 6)
- Human Chorionic Gonadotropin (hCG) Concentration(At Day 6 and last day of stimulation (up to 20 stimulation days))
- Number of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte Retrieval(On Day 5 after oocyte retrieval (up to 27 days after start of stimulation))
- Proportion of Participants With Ovarian Hyperstimulation Syndrome (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))
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Alanine Aminotransferase(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Creatinine(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Calcium(From the start of screening until the end-of-trial (up to approximately 6 months))
- Number of Stimulation Days(Up to 20 stimulation days)
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Potassium(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hemoglobin(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes/Leukocytes(From the start of screening until the end-of-trial (up to approximately 6 months))
- Progesterone (P4) Concentration(At Day 6 and last day of stimulation (up to 20 stimulation days))
- Estradiol (E2) Concentration(At stimulation Day 6 and last day of stimulation (up to 20 stimulation days))
- Number of Metaphase II (MII) Oocytes(On day of oocyte retrieval (up to 22 days after start of stimulation))
- Total Gonadotropin Dose(Up to 20 stimulation days)
- Frequency of Adverse Events (AEs)(From the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months))
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Sodium(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hematocrit(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils(From the start of screening until the end-of-trial (up to approximately 6 months))
- Ongoing Pregnancy Rate(8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation))
- Serum Follicle-stimulating Hormone (FSH) Concentration(At Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation))
- Luteinizing Hormone (LH) Concentration(At Day 6 and last day of stimulation (up to 20 stimulation days))
- Number of Oocytes Retrieved(On day of oocyte retrieval (up to 22 days after start of stimulation))
- Fertilization Rate(On Day 1 after oocyte retrieval (up to 23 days after start of stimulation))
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Aspartate Aminotransferase(From the start of screening until the end-of-trial (up to approximately 6 months))
- Early Pregnancy Loss(8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation))
- Follicular Development on Last Day of Stimulation(At last day of stimulation (up to 20 stimulation days))
- Serum Anti-Müllerian Hormone (AMH) Concentration(At the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening))
- Intensity of AEs(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Blood Urea Nitrogen(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Chloride(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Gamma Glutamyl Transferase(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Erythrocytes(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Leukocytes(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils/Leukocytes(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr African American(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes(From the start of screening until the end-of-trial (up to approximately 6 months))
- Proportion of Participants With Treatment-induced Anti-MENOPUR Antibodies. Overall as Well as With Neutralizing Capacity(Up to 28 days after end of the stimulation period (simulation period up to 20 days))
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Glucose(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr Non-afr. American(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Platelets(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils/Leukocytes(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes/Leukocytes(From the start of screening until the end-of-trial (up to approximately 6 months))
- Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils/Leukocytes(From the start of screening until the end-of-trial (up to approximately 6 months))
- Number of Participants With Potential Technical Malfunctions of the Administration Pen(Up to 20 stimulation days)
- Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters(From the start of screening until the end-of-trial (up to approximately 6 months))
- Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period(Up to 20 stimulation days)
- Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period(Up to 20 stimulation days)
研究者
研究点 (20)
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