A Comparison of Ongoing Pregnancy Rate Between Cleavage Stage and Early Compacting Embryo Transfer at 66±2 Hours After ICSI Using Single Step Culture Medium
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- The primary outcome measure was ongoing pregnancy rate, defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.
研究概览
简要总结
A comparison of ongoing pregnancy rate between cleavage stage and early compacting embryo transfer at 66±2 hours after ICSI using single step culture medium
详细描述
A prospective cohort study to compare the outcomes of transferring the early compacting and the cleavage day 3 embryos.
All participants were treated with a gonadotropin-releasing antagonist protocol according to local protocol. Recombinant follicle stimulating hormone was given for five days starting on the second or third day of the menstrual cycle at a starting dose individualized for each participant as follows: 150, 225 or 300 IU/day, respectively, in participants with anti-Müllerian hormone levels of <2.1 ng/mL, 0.7-2.1 ng/mL or <0.7 ng/mL. This dosage could then be titrated based on clinical judgement of the investigator. Follicular development was monitored using ultrasound scanning and measurement of estradiol and progesterone levels, starting on day five of stimulation; scanning and hormonal measurements were repeated every two to three days, depending on follicle size. An antagonist was routinely used on day five until the day of human chorionic gonadotropin administration. Criteria for administration of recombinant human chorionic gonadotropin (5,000 IU) was the presence of at least two leading follicles of 17 mm in diameter. Oocyte retrieval was performed 36 hours after recombinant human chorionic gonadotropin administration.
Insemination was performed using intra-cytoplasmic sperm injection at three to four hours after oocyte retrieval; only matured oocytes were inseminated. Fertilization check was performed under inverted microscope at 16-18 hours after insemination. Embryo evaluation was performed on day 3 at fixed time point after fertilization (66±2 hours) using the Istanbul consensus. As a rule, two useful embryos are transferred in patients if having either early compaction or still on cleavage stage.
Early compaction embryo transfer group: transfer of 2 utilizable compacting embryos.
Cleavage stage embryo transfer group: transfer of 2 utilizable non-compacting embryos have 7-9 cells with under 20% fragmentation.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •IVF treatment for infertility
- •Controlled ovarian hyperstimulation by GnRH antagonist protocol.
- •IVF cycles ≤2
- •Eligible for transfer of 2 embryos on day 3
- •Have at least 2 embryos which are 7-9 cells and fragmentation ≤20%, that had either early compaction or still on cleavage stage
排除标准
- •Oocyte donation cycles
- •Abnormal uterine
- •Using GnRH agonist for triggering.
研究组 & 干预措施
Early compaction embryo group
patients have compacting embryos at 66±2 hours after ICSI
干预措施: Compacting embryo transferring (Other)
Cleavage stage embryo group
patients have non-compacting embryos with 7-9 cells, under 20% fragmentation. at 66±2 hours after ICSI
干预措施: Non- compacting embryo transferring (Other)
结局指标
主要结局
The primary outcome measure was ongoing pregnancy rate, defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.
时间窗: 12 weeks
次要结局
- Ectopic pregnancy rate, defined as the ectopic nidation of a pregnancy, confirmed with sonography or laparoscopy(7 weeks)
- Miscarriage rate, defined as the loss of a pregnancy prior to 12 weeks gestation(12 weeks)
- Implantation rate (number of gestational sacs on ultrasound at 7 weeks / total number of embryos transferred x 100).(7 weeks)
- Clinical pregnancy rate, defined as the presence of a gestational sac under ultrasonography(7 weeks)
研究者
Manh Tuong Ho
Director
Vietnam National University