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临床试验/NCT00633347
NCT00633347已完成4 期

Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation

Instituto Valenciano de Infertilidad, IVI VALENCIA1 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
570
试验地点
1
主要终点
clinical pregnancy rate

研究概览

简要总结

Oocyte donation is a well established procedure in assisted reproduction treatments (ART). It is demonstrated that the use of hormonal substitution therapy, for the synchronization of the cycles between the recipients and the donors, provides good results, similar to the ones obtained with the natural cycle. In the patients - recipients with preserved ovarian function, the recipient's natural cycle is annulled, thus preventing the spontaneous Luteinizing Hormone surge. Simultaneously and while waiting for the suitable donor, her endometrium is prepared. When the donation occurs and fertilization with the husband sperm takes place, her cycle is stimulated again in order to synchronize her window of implantation with the donor's ovulation.

Two different medications are commonly used to inhibit spontaneous ovulation: either GnRHa agonist or GnRH antagonists. The present study consists of the comparison between the single dose GnRH agonist (Decapeptyl 3,75 IM) and the 7 day dosage of GnRH antagonist (Cetrotide 0,25 mg). The administration of GnRHa is used fundamentally as a long liberation formulation, administered in a single intramuscular injection (IM), which is more practical in terms of use. Nevertheless, the unnecessary persistence and the potentially unfavorable action of GnRHa during the luteal phase and early gestation have questioned its use. The recovery of the Hypophysarian function begins only 8 weeks after the single injection of long liberation of triptorelina 3.75 mg. The GnRH antagonist (Cetrotide 0,25 mg) makes the hypofisary inhibition shorter than with the analogues and can prepare similar endometrium characteristics as a natural cycle. The recipients will be assigned randomly to a group of treatment or another.

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 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • infertile females with preserved gonadal function
  • ages 18 - 43 years old

排除标准

  • BMI: > 28
  • recurrent miscarriages
  • severe male factor
  • important miomas
  • > 44 years old

研究组 & 干预措施

A

Active Comparator

A: Antagonist

干预措施: Antagonist GnRH Cetrotide (Drug)

A

Active Comparator

A: Antagonist

干预措施: Agonist GnRH Acetate Triptoreline (Drug)

B

Active Comparator

Agonist GnRH

干预措施: Agonist GnRH Acetate Triptoreline (Drug)

结局指标

主要结局

clinical pregnancy rate

时间窗: 1 month

次要结局

  • implantation rate(1 month)

研究者

发起方
Instituto Valenciano de Infertilidad, IVI VALENCIA
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmina Vidal, MD

Gynaecologist IVI valencia; Principal Investigator

Instituto Valenciano de Infertilidad, IVI VALENCIA

研究点 (1)

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