Effect of Timing of Oocyte Denudation Before ICSI and Its Results in an Oocyte Donation Model: a Cluster Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 2
- 主要终点
- Number of M2 oocytes at injection
研究概览
简要总结
Analyze the effect of preincubation time of oocyte on the results of ICSI in a oocyte donation model.
详细描述
There is an intense communication inside the follicular structure. Bidirectional information between the oocyte and the granulosa cells is needed for a normal follicular development and oocyte competence.
There are conflicting results on the effect of pre-incubation time in ICSI.
It is not clear the proper time to denudate the oocyte from the somatic cells prior to ICSI, and some authors describe a negative impact of the premature cummulus removal on the ICSI results.
The aim of this study is to investigate wheter a preincubation time between oocyte retireval and injection has any effect on the ICSI ( intracytoplasmatic sperm injection) results .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Oocytes retrieved from healthy donors, younger than 32 years old , with proven maternity(preference), who meet the admission criteria of ovodonation program:
- •The oocytes included will be the product of antagonist stimulation protocol and with Gnrh agonists trigger. (see annex)
- •Healthy women under 50 years of age , who meet the criteria as receptors into the ovodonation program.
- •Oocytes retrieved after 36.5 h + -1 h of administration of triptorelin acetate.
- •Only mature oocytes, in stage MII, will be included and injected.
- •Use of fresh or thawed semen for the ICSI.
排除标准
- •Cases of severe male factor such as azoospermia or severe oligo-astheno-teratospermia( alone or combinated)
- •Sperm samples from surgical procedures (biopsy / testicular or epididymal puncture)
- •Donors with a polycystic ovarian profile, according to The Androgen Excess and PCOS Society (AES),
- •Thawed donated oocytes
- •Oocytes from patients who have previously donated within a period of less than three months.
- •Donors whith poor response (oocyte retrieved less than < 4 oocytes).
- •Suspicion or signs of Endometriosis in donor patient.
结局指标
主要结局
Number of M2 oocytes at injection
时间窗: four hours after oocyte retrieval
Asessment of the number of M2 oocytes was made after the oocyte denudation and ICSI
Number of normal fertilized oocytes after ICSI
时间窗: 24 hours
Asessment of the normal fertilization rate was made 24 hours after the intervention.
Number of cleaving embryos
时间窗: 72 hours
The embryo cleavage was evaluated after 48 hours and 72 hours after the ICSI was performed.
Number of TOP embryos
时间窗: 72 hours
The embryos were morfologically classified into 4 categories . It considered TOP embryos those correctly fertilized at day 1, and with regular 6 to 8 cells at day 2 with less than 20% fragmentation and without multinuclear blastomeres.
次要结局
- Clinical pregnancy rate(6 to 7 week)
- Implantation rate(14 days after embryo trasfer)