An Observational Study "FOLLITROPIN" Comparing the Efficacy of Follitropin Alpha Biosimilar: the Real-world Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- IVFarma LLC
- 入组人数
- 5,484
- 试验地点
- 33
- 主要终点
- Number of Oocytes Retrieved
研究概览
简要总结
Aim to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.
详细描述
A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included:
monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with established causes of infertility and indications for the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation "On the use of assisted reproductive technologies, contraindications and limitations to their use" No. 107 n dated August 30,
- •Infertility due to female and/or male factor.
- •Presence of ovaries accessible for aspiration of follicles.
- •Anatomical and functional capability of uterus to bear pregnancy.
排除标准
- •Women with established contraindications to the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation "On the use of assisted reproductive technologies, contraindications and limitations to their use" No. 107 n dated August 30,
- •Presence of pregnancy
- •Hypersensitivity to follitropin alfa or excipients.
- •Ovarian cysts (not associated with polycystic ovarian syndrome), uterine hemorrhage of unclear etiology
- •Premature ovarian failure
- •Presence of clinically significant systemic disease
- •Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
- •Neoplasia
- •Narcomania, alcoholism
研究组 & 干预措施
Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH
The ovarian stimulation (OS) protocols included monotherapy protocols with using follitropin alpha biosimilar only and antagonists/agonists of of gonadotropin-releasing hormone (GnRH): ganirelix, cetrorelix, triptorelin, buserelin.
干预措施: Follitropin Alfa (Drug)
Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH
The OS protocols included: mixed protocols (recombinant with addition of urinary-derived gonadotropins) and antagonists/agonists of GnRH (ganirelix, cetrorelix, triptorelin, buserelin), where follitropin alpha biosimilar used for at least 5 days during OS.
干预措施: Follicle Stimulating Hormone/Luteinizing Hormone (Drug)
Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH
The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH.
干预措施: Follitropin Alfa (Drug)
Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH
The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH.
干预措施: Follitropin Alfa (Drug)
The overall protocols
The OS protocols included: (1) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH, (2) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH
干预措施: Follicle Stimulating Hormone/Luteinizing Hormone (Drug)
结局指标
主要结局
Number of Oocytes Retrieved
时间窗: From date of start of ovarian stimulation with follitropin alpha up to 15 days
The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the ovulation inducer (HCG or GnRH-agonist). Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646).
Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer
时间窗: At least 6 weeks after embryo transfer
Ongoing clinical pregnancy per embryo transfer (detection of gestational sac and heartbeat from 6 weeks after transfer), n (ongoing pregnancy rate per transfer with known outcome, %). Due to delayed embryo transfers, the analysed population for "Ongoing clinical pregnancy per embryo transfer" was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2007 embryo transfers (1542 with known outcome); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2213 embryo transfers (1800 with known outcome); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 1809 embryo transfers (1466 with known outcome) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 404 embryo transfers (334 with known outcome).
次要结局
- Total Dose of Follitropin Alpha Biosimilar Protocol, IU(From date of start of ovarian stimulation with follitropin alpha up to 16 days)
- Number of Mature Oocytes(From date of start of ovarian stimulation with follitropin alpha up to 15 days)
- Number of Fertilized Oocytes(From date of start of ovarian stimulation with follitropin alpha up to 16 days)