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临床试验/NCT06635538
NCT06635538已完成不适用

One-Shot Ovarian Stimulation Protocol: A Pilot Study Investigating the Endocrine Profile

Fundación Santiago Dexeus Font6 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
6
主要终点
Estradiol

研究概览

简要总结

The current prospective observational pilot study aims to evaluate the endocrine profile of a single-injection protocol (single CFA + daily oral administration of CC).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • AMH (Anti-Mullerian Hormone) 1.2-3.5 ng/ml or AFC 7-20
  • No family history of hereditary or chromosomal diseases
  • Body mass index (BMI) 18 to 30 kg/m2

排除标准

  • 未提供

研究组 & 干预措施

Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1

Experimental

干预措施: Monitoring cycle (Diagnostic Test)

Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1

Experimental

干预措施: Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1 (Drug)

Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1

Experimental

干预措施: Clomiphene Citrate (CC) 100 mg/day from D1 (Drug)

结局指标

主要结局

Estradiol

时间窗: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval

Estradiol levels

Progesterone

时间窗: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval

Progesterone levels

Follicle stimulating hormone (FSH)

时间窗: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval

FSH levels

Luteinizing hormone (LH)

时间窗: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval

LH levels

次要结局

  • Number of oocytes retrieved (COCs)(7 -20 days from initiation of ovarian stimulation)
  • Days of stimulation(7 -20 days from initiation of ovarian stimulation)
  • Number of MII oocytes(7 -20 days from initiation of ovarian stimulation)
  • Follicular Output Rate (FORT)(7 -20 days from initiation of ovarian stimulation)
  • Follicle-to-oocyte index (FOI)(7 -20 days from initiation of ovarian stimulation)
  • Cancellation rate(7 -20 days from initiation of ovarian stimulation)
  • Ovarian hyperstimulation syndrome (OHSS) rate(Until 15 days after punction)

研究者

发起方
Fundación Santiago Dexeus Font
申办方类型
Other
责任方
Sponsor

研究点 (6)

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