跳至主要内容
临床试验/NCT02213627
NCT02213627Unknown4 期

Randomized, Multicentric and Prospective Clinical Trial to Check the Cost-effectiveness of Corifollitropin Alfa vs. Recombinant FSH and/or HP-hMG

IVI Madrid1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
300
试验地点
1
主要终点
Number of oocytes and mature oocytes

研究概览

简要总结

The purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin administration) is effective in a controlled ovarian stimulation protocol in oocyte donors compared to daily gonadotropin administration (recombinant FSH or HP-hMG)

详细描述

In recent years, increasingly advances have been developed in terms of controlled ovarian stimulation protocols. These improvements have also moved into the way of administration of the different treatments, and at present, with subcutaneous devices, it is possible to offer advantages such as the ability to ensure administration of the correct dose or modify the dose before charging.

Simplification of ovarian stimulation protocols can help to reduce physical stress of the donors and the cancellation rate. The need for daily injection does not worsen the degree of compliance, but it generates some anxiety related to the administration of the right dose and / or the possibility of making a unconsciously mistake . Innovations in delivery devices could help reduce the stress associated with the stimulation itself and improve the welfare of the donor. Given these considerations, the need to develop a stimulation protocol that reduces the physical and emotional burden of reproduction treatment is established.

Corifollitropin alfa molecule is a full-length recombinant FSH generating a sustained effect of stimulation; a single subcutaneous injection of this drug is able to replace the first seven injections of any daily FSH preparation, so finally, the result would be an overall decrease in the number of injections needed for the whole cycle. Pharmacological and pharmacodynamic characteristics of corifollitropin alfa could facilitate the design of simple stimulation protocols and the need for fewer resources when monitoring the donor, including fewer clinic visits.

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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-35 years who meet the entry criteria for the IVI Donor Program:
  • Weight < 60 Kg
  • Women with at least 6 antral follicles per ovary
  • Women who will fit the protocoo during the period of the study
  • Women who give written consent to participate in the test

排除标准

  • Women with basal antral follicle count above 20 or below
  • Women with comorbidities, in the judgement of the investigator, that may interfere with the trearment of ovarian stimulation.

研究组 & 干预措施

Corifollitropin alfa

Experimental

From day 2-3 of mense, a single 100 microgram dose of corifollitropin alfa is administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.

干预措施: Corifollitropin alfa (Drug)

Recombinant FSH

Experimental

From day 2-3 of mense, daily injections of 150 IU of recombinant FSH will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.

干预措施: Recombinant FSH (Drug)

HP-hMG

Experimental

From day 2-3 of mense, daily doses of 225 IU of HP-hMG will be administered. Daily doses of 0.25 mg GnRH antagonist will start on day 6 of stimulation and a single dose of 0.2 mg of GnRH agonist will be administered for triggering final oocyte maturation.

干预措施: HP-hMG (Drug)

结局指标

主要结局

Number of oocytes and mature oocytes

时间窗: 3 months

次要结局

  • Fertilization and implantation rates(3 months)
  • Cost-effectiveness analysis(6 months)
  • Drop-out rate and cancellation rate(3 months)
  • Endocrine profile in serum and follicular fluid(3 months)
  • Apoptosis rate in cumulus cells(6 months)

研究者

发起方
IVI Madrid
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Requena

MD, PhD

IVI Madrid

研究点 (1)

Loading locations...

相似试验