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临床试验/NCT01338844
NCT01338844已完成4 期

A Prospective, Randomized, Double Blind, Study on the Clinical Efficacy Myo-inositol Versus D-chiro-inositol in Women Undergoing in Vitro Fertilization Embryo Transfer.

AGUNCO Obstetrics and Gynecology Centre3 个研究点 分布在 1 个国家开始时间: 2011年4月20日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
试验地点
3
主要终点
number of morphologically mature oocytes

研究概览

简要总结

Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other Assisted Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI).

The hormonal control of multiple follicular growth and maturation is a critical part of ART procedures since it maximizes the yield of embryos to be transferred, thus increasing the cumulative pregnancy rate.

Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and highly effective treatment in order to improve oocyte quality in patients undergoing IVF. Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable predictor of oocyte quality. High MI concentration in the FF directly correlates with high oocyte and embryo quality.

Another stereoisomer of Inositol was successfully used into clinical practice D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in hyperglycemic PCOS patients.

In the present study we aim to compare MI versus DCI supplementation on oocyte quality of women undergoing IVF-ET

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women undergoing IVF treatments
  • Body mass index <28
  • FSH <10IU/L
  • Normal uterine cavity, anatomy and functions

排除标准

  • Stage III or IV endometriosis
  • Premature ovarian failure
  • Poor responder

研究组 & 干预措施

D-Chiro-inositol

Experimental

Patients will receive 1.2g/day of D-chiro-inositol

干预措施: D-chito-Inositol (Dietary Supplement)

结局指标

主要结局

number of morphologically mature oocytes

number of grade 1 embryos

Total international units (IU) of recombinant FSH administrated

次要结局

未报告次要终点

研究者

发起方
AGUNCO Obstetrics and Gynecology Centre
申办方类型
Other

研究点 (3)

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