2023-506908-66-00招募中3 期
Usefulness of Corifollitropin alfa as alternative to conventional daily rFSH protocols in oocyte donors undergoing pituitary suppression with Medroxiprogesterona acetate (MPA).
Ivi Valencia S.L., Ivi Valencia S.L.1 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2023年12月13日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- Number of MII oocytes and mature oocyte rate
研究概览
简要总结
To compare the number of total oocytes and metaphase II (MII) oocytes obtained after controlled ovarian stimulation with α-Corifolitropin vs. β-Folitropin in donors in whom medroxyprogesterone acetate (MPA) has been used to prevent early luteinisation.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signature of subject's informed consent prior to any trial-related activity. - Age between 18 and 35 years (inclusive). - Regular menstrual cycle, 25 to 35 days (both inclusive). - Absence of physical and mental illness at the time of donation at the discretion of the investigator. - BMI 18-28 kg/m2 (both inclusive) at the time of donation. - No personal or family history of interest at the discretion of the investigator. - Normal uterus and ovaries, without organic pathology. - No polycystic ovaries. - Antral follicle count greater than 12 in the sum of the two ovaries at the time of the selection visit. - Normal karyotype. - Negative screening for infectious diseases (Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus and Syphilis). - General analysis with haemogram, haemostasis and biochemistry with parameters within normality.
排除标准
- •Concurrent participation in another clinical trial. - Previous participation in this clinical trial. - Any systemic or metabolic disorder (i.e.: diabetes...) that contraindicates the use of gonadotrophins. - Personal history of thrombophlebitis and thromboembolic phenomena and AHT. - Severe hepatic insufficiency, cardiovascular disease. - Suspicion or evidence of breast or hormone-dependent genital organ malignancy - known hypersensitivity to MPA or its excipients - Use of long-term hormonal contraception (hormonal IUDs or subcutaneous implants) at least 1 month prior to inclusion - Any reason for exclusion from the oocyte donation programme
结局指标
主要结局
Number of MII oocytes and mature oocyte rate
Number of MII oocytes and mature oocyte rate
次要结局
未报告次要终点
研究者
Juan Giles Jumenez
Scientific
Ivi Valencia S.L.
研究点 (1)
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