Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up.
研究概览
简要总结
The purpose of this study is to compare the natural cycle (without any medication) with the well-established artificial cycle in an egg donation program.
详细描述
Oocyte donation is an assisted reproduction technique well established. In patients with ovarian function, it is necessary to synchronize the cycle of the egg donor with the recipient, usually through endometrial preparation of the recipient by artificial cycle, by administering a GnRH agonist on day 21 of cycle and then administered increasing doses of estrogen therapy to achieve adequate endometrial thickness.
The necessity of synchronization between donors and recipient, has made possible not routinely the natural cycle for oocyte donation.
The investigators have recently introduced oocyte vitrification and it allows us to plan the egg donation in a different way. Now the investigators can previously cryopreserved donor oocytes and at the time that the investigators have a compatible receiver, then, plan the donation In this study it will be possible compare the results of oocyte donation cycles in terms of pregnancy rate, implantation and liveborn, depending on whether the recipient has made an artificial cycle of preparation endometrial or a natural cycle.
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 - 44 years old included
- •first oocyte donation cycle
排除标准
- •BMI: > 28
- •recurrent miscarriages (3 or more)
- •recurrent of implantation failure
- •severe male factor
- •important miomas
- •> 44 years old
- •Problems with the drugs used in the study
研究组 & 干预措施
Natural cycle
干预措施: observation natural cycle (Other)
Artificial cycle
Drugs: Agonist GnRH Acetate Triptoreline Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose. Estradiol Valerate, orally Initially 4 pills daily during 4 days, and after increase the dose to 6 mg orally daily.
Natural micronized progesterone, 400 mg/12 hours vaginal administration
干预措施: Agonist GnRH; estradiol Valerate; progesterone (Drug)
结局指标
主要结局
Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up.
时间窗: 12 months
Outcome of the study is measured by the pregnancy rates after IVF treatments of both arms.
次要结局
未报告次要终点