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临床试验/NCT04122729
NCT04122729Unknown不适用

Study of the N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in Controlled Ovarian Stimulation

Angelini Farmacéutica12 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年9月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
12
主要终点
Genotype of the N680S polymorphism of the FSHR gene

研究概览

简要总结

This project wants to determinate whether there is a relationship between the N680S polymorphism genotype of the FSHR gene and the nature of the FSH used in controlled ovarian stimulation.

It is a non-interventional, observational, cross-sectional and retrospective, national and multicenter study, in which a genetic test will be carried out to determine the genotype of the N680S polymorphism in samples of blood of patients who have undergone two cycles of controlled ovarian stimulation in the last 8 months.

详细描述

The investigators want to investigate whether the N680S polymorphism of the FSRH gene could affects ovarian response with different nature of the FSH used (human FSH and recombinant FSH) in patients undergoing two consecutive cycles of IVF/ICSI with controlled ovarian stimulation.

All patients who agree to participate in the study will have a blood sample taken on the same day as a routine extraction performed for the 2nd cycle of the controlled ovarian stimulation in accordance with the standard clinical practice of each hospital. The sample will be sent to the central laboratory to determine the genotype of the afore mentioned polymorphism and correlate it with the clinical results obtained with the two cycles of controlled ovarian stimulation.

In order to avoid any bias, the study population will follow a crossover design with respect to the type of FSH used in the first and second cycles of the COS (i.e., half of the recruited patients must have undergone a first cycle of COS with recombinant FSH and a second cycle with human FSH; and, conversely, the other half must have undergone a first cycle with human FSH and a second cycle with recombinant FSH). In order to avoid potential modifications to the inclusion criteria, the time elapsed between the two cycles should not exceed 6 months.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Genotype of the N680S polymorphism of the FSHR gene

时间窗: Through study completion, an average of 1 year

Genotype of the N680S polymorphism of the FSHR gene will be tested on blood samples

Oocytes retrieved

时间窗: Through study completion, an average of 1 year

Number of oocytes retrieved in each IVF/ICSI cycle with controlled ovarian stimulation used different nature of the FSH in each one (human FSH and recombinant FSH).

次要结局

  • Genotype of the N312S polymorphism of the LHCGR gene(Through study completion, an average of 1 year)

研究者

发起方
Angelini Farmacéutica
申办方类型
Industry
责任方
Sponsor

研究点 (12)

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