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临床试验/NCT04576546
NCT04576546已完成不适用

Use of Inositols Within IVF Protocols to Reduce Gonadotropin Administration

Lo.Li.Pharma s.r.l2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
FSH units/retrieved oocyte

研究概览

简要总结

Ovarian hyperstimulation syndrome (OHSS), although quite uncommon, represents the most serious complication of ovulation induction during in-vitro fertilization (IVF) protocols. The syndrome is triggered by exaggerated ovarian response to gonadotropins, which eventually leads to pathological manifestations that range from mild symptoms, such as abdominal discomfort, to life-threatening complications in the most severe cases. Prevention is paramount during fertilization programs and requires assessment of risk factors and close monitoring of risk markers. Clinicians quite generally consider unusually elevated estrogen levels as both indicator for OHSS and one possible etiological factor. In this scenario, myo-inositol (MYO) treatment proved to reduce the amount of FSH units and the duration of the stimulation protocol, decreasing the risk of OHSS onset. On the other hand, inconclusive evidence is available about the effect of D-chiro-inositol (DCI) supplementation within assisted reproductive treatments. The aim of the proposed pilot study is to assess the effect of DCI supplementation on the doses of FSH used in IVF-ET protocols, also with respect to MYO treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Women undergoing IVF-ET procedure
  • HOMA-IR index < 2.0
  • AMH in the range 1.0 - 2.0 ng/ml

排除标准

  • History of cancelled IVF cycles
  • BMI < 20 kg/m2 or ≥ 30 kg/m2
  • Diagnosis of PCOS
  • Thyroid diseases
  • Presence of co-morbidities

结局指标

主要结局

FSH units/retrieved oocyte

时间窗: 1 day (single time-point at ovulation)

number of IU of recombinant FSH administered, normalized on the number of oocytes retrieved during the pick-up

次要结局

  • embryo quality(1 day (single time-point at embryo transfer))
  • Total FSH (IU)(1 day (single time-point at ovulation))
  • Duration of the stimulation(1 day (single time-point at ovulation))
  • number of viable oocytes(1 day (single time-point at oocyte pick-up))
  • oocyte quality(1 day (single time-point at oocyte pick-up))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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