Prospective Randomized Clinical Trial to Test the Efficacy of a Biosimilar Recombinant Follicle Stimulating Hormone (FSH)vs. Urinary FSH in an Oocyte Donation Program
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Number of metaphase II oocytes
研究概览
简要总结
Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step in simplifying fertility treatments, making them easier to manage and more accessible to patients. Taking in mind these arguments ,the study is proposed for determining equivalence in terms of biological effectiveness of an ovarian stimulation protocol with biosimilar recombinant FSH stimulation protocol vs. urinary FSH in oocyte donation program.
详细描述
Biosimilar products are drugs "like" biotechnological origin to other innovative biological medicines and that can be marketed once the patent has expired. These drugs are intended to achieve the same therapeutic benefit as biological medicinal resembles.
Because of the similarity in both the active substance in the formulation, it is intended to demonstrate the equivalence between the biosimilar medicine of recombinant FSH and FSH of urinary origin in terms of fitness.
The investigators' main objective is to perform a non-inferiority trial of biosimilar recombinant FSH product compared to a conventional ovarian stimulation protocol with urinary FSH in relation to the number of oocytes retrieved and the number of metaphase II oocytes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-35 years who meet the criteria for entry into the oocyte donor program and that are going to undergo controlled ovarian stimulation
排除标准
- •Patient with a basal antral count> 20 follicles in total or <6 antral follicles per ovary
- •Patients with comorbidities that, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation
- •The presence of ovarian cysts that judgment of the investigator would interfere with the stimulation or may pose a risk to the donor
- •BMI <18 kg / m2
- •BMI> 30 kg / m2
- •Severe hypersensitivity to drugs with similar structure
研究组 & 干预措施
Biosimilar recombinant FSH
Under current practice, 65 participants will be stimulated with 150 international units (IU)/day biosimilar recombinant FSH, .Daily doses of 0.25 miligrams gonadotropin-releasing hormone (GnRH) antagonist will start on day 6 of stimulation. From this day may also vary the dose of recombinant FSH biosimilar according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.1 miligram GnRH agonist will be administered for triggering final oocyte maturation
干预措施: Biosimilar recombinant FSH (Drug)
Urinary FSH
Under current practice, 65 participants will be stimulated with 150 IU/day of urinary FSH. Daily doses of 0.25 miligrams gonadotropin-releasing hormone (GnRH) antagonist will start on day 6 of stimulation From this day may also vary the dose of urinary FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.1 miligram GnRH agonist will be administered for triggering final oocyte maturation
干预措施: Urinary FSH (Drug)
结局指标
主要结局
Number of metaphase II oocytes
时间窗: 1 day
次要结局
- Fertilization rate(1 day)
- Percentage of cryopreserved embryos(2 weeks)
- Implantation rate(2 weeks)
- Cancellation rate(1 week)
- Degree of satisfaction (numbers 0-10)(1 month)
- Apoptosis rate in granulosa cells(1 month)
- Days of treatment(2 weeks)
- Total dose of gonadotropins (IU)(2 weeks)
- Estradiol concentration the day of human chorionic gonadotropin (hCG) administration (picograms/mililiterl)(1 day)
- Progesterone concentration the day of hCG administration (nanograms/mililiter)(1 day)
研究者
Antonio Requena
MD, PhD
IVI Madrid