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临床试验/NCT01887652
NCT01887652已完成不适用

Individualization of Controlled Ovarian Stimulation Using Anti-mullerian Hormone as a Biomarker of Ovarian Response Maximizes the Beneficial Effects of Treatment and Minimizes Complications and Risks.

ANDROFERT - Clinica de Andrologia e Reproducao Humana2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
250
试验地点
2
主要终点
number of oocytes retrieved

研究概览

简要总结

The purpose oh the study is to determine the usefulness of anti-Mullerian hormone (AMH) to identify women at risk of excessive and poor response in controlled ovarian stimulation (COS) for in vitro fertilization (IVF), and the clinical impact of applying individualized COS strategies in these subsets of patients.

详细描述

A group of 130 women undergoing conventional COS after pituitary down-regulation for IVF will be studied to determine the best cut-off points of AMH, using receiver operating characteristic (ROC) analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved). The inclusion criteria is any patient with indication of IVF treatment. Subsequently, a different group of 120 women (with the same criteria) will be assessed using AMH before starting COS, and treatment strategy will be individualized according to AMH results (iCOS). Mild stimulation using daily doses (112.5 to 150 IU) of recombinant follicle stimulation hormone (rec-hFSH) or rec-hFSH combined with recombinant luteinizing hormone (LH) supplementation (375 IU total daily dose) will be given to patients identified as at risk of excessive and poor response, respectively. It will evaluated: number of oocytes, clinical pregnancy rates (defined as fetal heartbeat on ultrasound performed 4 weeks after the transfer of embryos) and occurrence of Ovarian hyperstimulation syndrome). Outcomes will be compared between the groups who received conventional and iCOS using chi-square and Fisher exact tests.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women with in vitro fertilization treatment indication

排除标准

  • 未提供

结局指标

主要结局

number of oocytes retrieved

时间窗: 1 day (on the day of oocyte retrieval)

number of oocyte retrieved classified as: poor response: ≤4 oocytes normal response: 5 - 19 oocytes excessive response: ≥20 oocytes

次要结局

  • occurrence of ovarian hyperstimulation syndrome(4 weeks after embryo transfer)
  • cancellation(on the 8th day of ovarian stimulation)
  • clinical pregnancy rate(4 weeks after embryo transfer)

研究者

发起方
ANDROFERT - Clinica de Andrologia e Reproducao Humana
申办方类型
Other
责任方
Sponsor

研究点 (2)

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