Assessment of Reproductive and Perinatal Outcomes According to the Fertilisation Technique in Non-Male Factor Infertility Patients: Conventional in Vitro Fertilisation Versus Intracytoplasmic Sperm Injection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Usable blastocyst rate
研究概览
简要总结
The aim of this clinical trial is to evaluate the efficiency of two fertilization techniques used in Assisted Reproduction: conventional In Vitro fertilization (cIVF) and Intracytoplasmic Sperm Injection (ICSI), in terms of in-vitro and clinical results, in non-male infertility patients, comparing them in sibling oocytes.
The main questions it aims to answer are:
Does ICSI result in better fertilization rate, blastocyst rate or usable blastocyst rate? Does ICSI result in better pregnancy, clinical pregnancy and live birth rates?
Researchers will compare cIVF to ICSI in sibling oocytes to assess if a technique offers better results.
Participants undergoing an IVF/ICSI cycle will have their oocytes randomly divided in two groups: the oocytes from one group will be fertilized using cIVF and the oocytes from the other group using ICSI.
详细描述
It is a prospective randomized study performed in the Reproduction Unit of Hospital Clinico San Carlos, in Madrid.
The study involves In Vitro Fertilization cycles with at least 6 oocytes retrieved and with normal semen parameters according to WHO.
The objective is to compare conventional In Vitro Fertilization (cIVF) and Intracytoplasmic Sperm Injection (ICSI) in sibling oocytes from the same cohort.
The oocytes obtained after the ovum pick up will be randomly divided in two groups and the fertilization technique (cIVF or ICSI) will be randomly assigned to each group.
Maturity stage, fertilization and embryo development to blastocyst will be individually recorded for every oocyte. Additionally, the destination of every embryo (transferred, cryopreserved or discarded) will be registered. This decision will be based just on embryo quality, irrespective of the fertilization technique.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with at least 6 fresh, own oocytes.
- •Patients with culture to blastocyst stage for all the embryos.
- •Non-male factor infertility patients: semen sample with a good progresive sperm count, appropriate for cIVF.
排除标准
- •Patients not willing to sign the informed consent. Patients not understanding Spanish.
- •Patients with severe endometriosis
- •Patients with recurrent implantation failure: at least 2 miscarriages or at least 3 transfers with good-quality embryos without pregnancy.
- •Patients presenting total fertilization failure or very poor results in any of the two techniques in previous cycles
结局指标
主要结局
Usable blastocyst rate
时间窗: From oocyte retrieval to 6 days after
Percentage of oocytes that develop to blastocyst stage and are transferred of cryopreserved
Fertilization rate
时间窗: From oocyte retrieval to 24 hours later
Percentage of oocytes that show normal fertilization
Blastocyst rate
时间窗: From oocyte retrieval to 6 days after
Percentage of oocytes that develop to blastocyst stage
次要结局
- Pregnancy rate(From embryo transfer to 14 days later)
- Clinical pregnancy rate(From embryo transfer to 4 weeks later)
- Live birth delivery rate(From embryo transfer to 40 weeks later)
研究者
Maria Dolores Cuquerella Fernandez-Vazquez
Principal Investigator
Hospital San Carlos, Madrid