Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start (Day 4) vs. Corifollitropin-alfa Standard Start (Day 2) in Expected Poor, Normal and High-responders Undergoing IVF/ICSI

University of Turin, Italy1 个研究点分布在 1 个国家目标入组 113 人开始时间: 2017年4月1日最近更新: 2019年1月25日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 113
试验地点: 1
主要终点: number of retrieved oocytes

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF. The primary analysis will be also performed in specific subgroups of patients: expected poor-responders, expected normal responders and expected hyper-responders

详细描述

The investigators hypothesize that:

CF-alfa late start (day 4) will show comparable efficacy in terms of number of retrieved oocytes versus standard CF-alfa (day 2) protocol. In certain groups of patients, CF-alfa late start might show differences in terms of efficacy such as in poor-responder patients.
CF-alfa late start (day 4) will obtain similar results in terms of vital pregnancy rates with a similar safety profile with respect to COS performed using CF-alfa standard administration (day 2) in expected normal, poor, or high responders.
Oocytes and embryos obtained using CF-alfa late start will have comparable morphological features and development potential than those obtained with CF-alfa standard.
The patients' satisfaction will possibly be higher using CF-alfa late start than with CF-alfa standard expecially in those patients who will not have the need to add further daily recFSH injections

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: 18 Years 至 43 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•aged 18- 43 years
•Male or tubal infertility with indication for IVF treatment
•No previous IVF treatments in the past two months
•No history of previous Ovarian Hyperstimulation Syndrome (OHSS)
•No previous IVF cycle with more than 30 growing follicles ≥ 11 mm
•Antral Follicle Count (AFC) <20
•No ovarian cyst nor malignant ovarian tumour, breast, uterus or central nervous cancer

排除标准

•AMH < 0.2 ng/ml
•Età > 43 anni