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临床试验/NCT04193930
NCT04193930撤回不适用

Soft Versus Conventional Protocol in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles for Poor Responders

Assiut University1 个研究点 分布在 1 个国家开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Total gonadotrophins dose

研究概览

简要总结

During assisted reproduction technology treatments like in vitro fertilization, some patients give a poor ovarian response to controlled ovarian hyperstimulation. The European Society of Human Reproduction and Embryology consensus defined poor response to ovarian stimulation during in vitro fertilization with Bologna criteria.

Bologna criteria: At least two of the following three features must be present:

(i) Advanced maternal age (≥40 years). (ii) Previous Poor responders (≤3 oocytes with a conventional stimulation protocol).

(iii) An abnormal ovarian reserve test Most controlled ovarian hyperstimulation regimens currently used for expected poor responders are based on using a high daily dose (300- 450 IU/day) of exogenous gonadotropins. Giving a high gonadotropin dose obviously increases the cost of in vitro fertilization, a consequence that would be acceptable if paralleled by an improvement in in vitro fertilization outcome. Unfortunately, however, the available data suggest that increasing the daily gonadotropins dose may increase the number of retrieved oocytes, but not the final success rate of in vitro fertilization.

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
40 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Advanced maternal age (≥40 years) .
  • Previous Poor responders (≤3 oocytes with a conventional stimulation protocol).
  • An abnormal ovarian reserve tests

排除标准

  • Hyper or Normal responders patients.
  • Endocrine or metabolic diseases like hyperprolactinoma, hypothyroidism,...etc
  • Patients with a severe male factor abnormality. 4-Patients with systemic disease such as chronic renal disease, chronic liver disease, etc

研究组 & 干预措施

Soft ovarian stimulation protocol

Other

干预措施: Letrozole (Drug)

Soft ovarian stimulation protocol

Other

干预措施: Menotropins (Drug)

conventional ovarian stimulation protocol

Other

干预措施: Menotropins (Drug)

conventional ovarian stimulation protocol

Other

干预措施: recombinant Follicular stimulating hormone (Drug)

结局指标

主要结局

Total gonadotrophins dose

时间窗: 14 days

次要结局

  • Duration of ovarian stimulation(14 days)
  • Endometrial thickness(14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Lecturer

Assiut University

研究点 (1)

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