Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation
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
- 是
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
A: Antagonist
干预措施: Antagonist GnRH Cetrotide (Drug)
A
A: Antagonist
干预措施: Agonist GnRH Acetate Triptoreline (Drug)
B
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
Carmina Vidal, MD
Gynaecologist IVI valencia; Principal Investigator
Instituto Valenciano de Infertilidad, IVI VALENCIA
