Utility of Deferred Embryo Transfer in an In Vitro Program With Single Embryo Transfer Policy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Live birth rate
研究概览
简要总结
Single embryo transfer decreases the multiple pregnancy rate and its complications. However, studies are needed to help increase the effectiveness of this technique to increase its use, which undoubtedly improves the safety of our patients.
Objectives:
To assess the results of IVF / ICSI cycles with single embryo transfer, in terms of both pregnancy and live birth rates, comparing a group of patients in which an elective delayed cryotransfer of an embryo without fresh transfer is performed (experimental group ), with patients in whom a fresh embryo is transferred electively.
Methodology:
A prospective randomized clinical trial with two arms in parallel, not blinded, including 138 couples using an IVF / ICSI cycle at the Reproduction Unit of the Hospital Universitario Virgen de las Nieves de Granada. The inclusion criteria classify them as having a good reproductive prognosis, and the patients will follow an ovulation treatment protocol with GnRH agonists or antagonists. Couples will undergo an IVF / ICSI cycle, randomly assigned to:
- Group I (experimental): fresh transfer is not performed, the best quality embryo is cryopreserved. Elective transfer in a later cycle of the cryopreserved embryo.
- Group II (control): fresh transfer of the best quality embryo.
详细描述
The study has been designed as a prospective, randomized, two-arm, parallel, unblinded study, during which the investigators will include 138 couples (69 in each group) of IVF / ICSI users. Cycles canceled or punctured but without embryo transfer (either due to not obtaining oocytes, non-fertilization or arrest of embryonic development) will not be included in the study. The assignment of the couples to each of the groups will be carried out by means of a consecutive random sampling procedure. The randomization list will be created specifically for this project and will be kept safely by someone not included in the research team:
- Group I (experimental): fresh transfer is not performed, the best quality embryo is cryopreserved. Elective transfer in a later cycle of the cryopreserved embryo.
- Group II (control): fresh transfer of the best quality embryo.
Subjects of study:
Patients who come to the Human Reproduction Unit of the Virgen de las Nieves University Hospital to perform a first or second cycle of IVF / ICSI. Couples will be selected according to inclusion criteria that classify them as good reproductive prognosis (which is consistent with the usual eSET practice).
Couples will be able to participate in the study for only one cycle. Each couple will be interviewed to explain the characteristics of the study and will be given an Information Sheet. Written informed consent must be obtained from each couple. The person outside the research team who is guarding the randomization list will assign the corresponding treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study arm is masked until the oocyte recovery date, when we have to give a date in the control arm for the embryo transfer.
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 19-29 kg/m2
- •AMH > 0.5 ng/mL
- •FIV/ICSI cycle: first or second
排除标准
- •uterus surgery
- •endometriosis
- •miscarriage >1
- •REM < 1 million spz
结局指标
主要结局
Live birth rate
时间窗: 15 months
Live birth rate after freeze-all or fresh embryo strategy in an Assisted Reproduction program
次要结局
- Implantation rate(4 months)
- Miscarriage rate(4 months)
- Metaphase II rate(1 month)
- Fertility rate(1 month)
- Adverse events rates(15 months)
- Good embryo quality rate(1 month)
- Survival to devitrification rate(4 months)
- Gestation rate(4 months)
- Newborn weight(15 months)
研究者
Ana Clavero Gilabert
Medical Clinical laboratory especialist
University Hospital Virgen de las Nieves