NCT02490150已完成4 期
Administration of Corifollitropin Alfa on Day 5 Versus Day 7 After Last Oral Contraceptive Pill in a GnRH (Gonadotropin-releasing Hormone ) Antagonist Protocol in Donors
Institut Universitari Dexeus1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年2月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- total dosis of rFSH (IU)
研究概览
简要总结
To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Women 18-35 y old ,with regular spontaneous menstrual cycles of 25-30 days length
- •Who had vaginal sexual intercourse or have no inconvenient for vaginal explorations
- •Donors can´t have more than 6 children (neither own or after donations)
- •Not be adopted or being born after a gamete donation pregnancy
- •BMI between 18-28 kg/m2
- •Height > 1.55cm
- •Gynecological and general examination with Pap smear, HIV, HCV (hepatitis C virus ), HBV (hepatitis B virus ) and RPR(rapid plasma reagin test ) negative serology, and with normal karyotype
- •No abnormal Psychological profile
- •Discard any disease: blood disorders, neurodegenerative/psychiatric diseases, Fragile X Syndrome, cystic fibrosis carrier, oncology diseases.
- •Without psychological/psychiatric family history
- •Will conform to the protocol for the duration of the study
- •Willingness of adhesion to protocol during the whole study period
- •Signed informed consent
排除标准
- •Polycystic ovarian syndrome
- •Antral follicle count > 20
- •Hypersensitivity to the active substance or any of the excipients
- •Abnormal vaginal bleeding of unknown ethiology
- •Presence of ovarian cysts or increased size ovaries
- •History of ovarian hyperstimulation syndrome
- •Previous controlled ovarian stimulation cycle with more than 30 follicles ≥ 11mm
- •Previous abdominal surgery that contraindicated the practice of follicular puncture
- •HIV, HCV, HBV positive serology in women or partner
- •Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors...)
研究组 & 干预措施
Day 5
Experimental
Administration of corifollitropin alfa on Day 5 after last oral contraceptive pill in a GnRH antagonist protocol in donors.
干预措施: Corifollitropin alfa (Drug)
Day 7
Active Comparator
Administration of corifollitropin alfa on Day 7 after last oral contraceptive pill in a GnRH antagonist protocol in donors.
干预措施: Corifollitropin alfa (Drug)
结局指标
主要结局
total dosis of rFSH (IU)
时间窗: donors will be followed until the end of stimulation period, an expected average of 15 days
次要结局
未报告次要终点
研究者
Ignacio Rodriguez
MD.
Institut Universitari Dexeus
研究点 (1)
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