Open Randomized Study Comparing Clinical Efficacy of Corifollitropin Alfa (Elonva) in Combination With Menotropin (Merional) With Follitropin and Lutropin Alfa (Pergoveris) for Ovarian Stimulation in Expected Suboptimal Responders
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of cumulus-oocyte complexes (COCs)
研究概览
简要总结
In an opened randomized study of women undergoing in vitro fertilization with expected suboptimal response to controlled ovarian stimulation (Poseidon Group 2b) investigators will examine clinical efficacy and safety of two stimulation protocols: Corifollitropin alfa (Elonva) in combination with menotropin (Merional) versus Follitropin alfa and lutropin alfa (Pergoveris).
详细描述
Patients, found eligible for the study, will be randomized (envelope method) into two arms in 1:1 ratio at the start of stimulation (menstrual cycle day 2-3, randomization day): Arm A - ovarian stimulation with Corifollitropin alfa in combination with menotropin; Arm B - ovarian stimulation with Follitropin alfa and lutropin alfa.
At the first day of controlled ovarian stimulation (COS) participants in the first group will receive a single injection of Corifollitropin alfa 150 mcg followed by daily menotropin administration at the dose of 150 international unit (IU) from stimulation day 1 to day 7 and at the dose of 300 IU from day 8 up to the end of stimulation.
Ovarian stimulation in group B will be performed with daily 300 IU of Follitropin alfa and lutropin alfa starting on menstrual cycle day 2-3.
For all subjects, a fixed dose of gonadotropin-releasing hormone (GnRH) antagonist will be injected daily as soon as one of the follicles reaches the ≥14 mm diameter and stopped one day before oocyte pick up (OPU); ovulatory dose of human chorionic gonadotropin (hCG) could be administered when at least one follicle reaches 16.5 mm in diameter.
Retrieved oocytes following fertilization (conventional IVF or ICSI) will be cultured to morula or blastocyst stage followed by ultrasound guided single or double embryo transfer (ET day, performed 4-5 days after OPU).
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
- 35 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age between 35-41 years;
- •BMI 17,5-30 kg/m2;
- •Expected suboptimal responders (according to Poseidon classification, 2016, Group 2b): patients with suboptimal ovarian reserve prestimulation parameters in terms of antimüllerian hormone (AMH) and antral follicle count (AFC): AFC 5-9, AMH ≥0.8 ng/mL;
- •Early follicular phase follicle stimulating hormone (FSH) ≤15 IU/L;
- •Presence of viable spermatozoa in partner's sperm;
- •Signed informed consent.
排除标准
- •Pre-existing medical condition preventing or interfering with IVF treatment: any clinically significant systemic disease; inherited or acquires thrombophilia and thromboembolism; endocrine or metabolic abnormalities; moderate or severe impairment of renal or hepatic function; any oncological diseases in anamnesis; known history of recurrent miscarriage, abnormal karyotype of both partners; currently active pelvic inflammatory disease;
- •Abnormal IVF screening tests: Papanicolaou test, Syphilis, HIV 1&2, Hepatitis B, Hepatitis C, Chlamydia, and Gonorrhea;
- •Presence of uterine pathology: Asherman's Syndrome, endometrial polyps, nodus form of adenomyosis or uterine fibroids ≥3 mm in diameter;
- •Visualization of ovarian cysts ≥25 mm, endometriomas or hydrosalpinx;
- •One or more follicles ≥8 mm on randomization day.
研究组 & 干预措施
Corifollitropin alfa and menotropin
Elonva 150 mcg, Merional 150-300 IU
干预措施: Corifollitropin alfa and menotropin (Drug)
Follitropin alfa and lutropin alfa
Pergoveris 300 IU
干预措施: Follitropin alfa and lutropin alfa (Drug)
结局指标
主要结局
Number of cumulus-oocyte complexes (COCs)
时间窗: 3-4 weeks after ET
Number of COCs, obtained during oocyte pick up (OPU), after controlled ovarian stimulation (COS) in two protocols
次要结局
- Implantation rate(3-4 weeks after ET)
- Duration of stimulation(2-4 weeks after randomization)
- Clinical pregnancy rate(5-6 weeks after randomization)
- Number of mature (MII) oocytes(2-4 weeks after randomization)
- Frequency of side reactions(2-4 weeks after randomization)
- Cycle cancellation rate(6-7 weeks after randomization)
- Number of follicles at the end of stimulation(2-4 weeks after randomization)
- Dose adjustment frequency(2-4 weeks after randomization)
- Number of participants with optimal or suboptimal response to COS(2-4 weeks after randomization)
研究者
Valeria Muller
PhD, MD
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology