The Effects of Using Microfluidic Separation Sperm Selection for Unexplained Infertility(UEI) and Reccurrent Implantation Failure(RIF)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Implantation Rate
研究概览
简要总结
In order to increase the likelihood of achieving IVF-treated pregnancy, good quality embryo transfer is important. To get good quality embryos, good quality gametes are needed. The selection of sperm is regulated according to the changing and mobility characteristics of today's conditions. The choice of multi-fluid sperm is thought to provide better sperm to obtain the environment in physiological conditions. Better embryo transfer to achieve better sperm elongation will increase the likelihood of pregnancy.
详细描述
Patients will be treated with conventional IVF treatment. A vaginal ultrasound (US) examination will be perform on day 3 of the cycle for assessment of ovarian size and to exclude patients with large ovarian cysts. If a cyst >20 mm is present, the cycle will cancel. At an initial dose of 225 IU, hMG will be given daily by IM injection commencing on day 3 of the cycle. The dose will be adjusted as re- quired depending on the E2 (estradiol) level. Daily endovaginal US examinations for follicle growth assessment will be started when the E2 level reached 275 pg/mL (1,000 pmoljL). When at least two follicles would reach 18 mm in diameter, 5,000 IU of hCG will be administered intramuscularly. Oocyte retrieval will be performed vaginally under US guidance 36 hours later. Sperm for ICSI procedure of oocytes will be prepared by a standard swim-up technique using for control group and sperm chip method will be used for study group for Unexplained Infertility and Recurrent Implantation Failure group. Uterine transfer of embryos will be carry out fifth day after oocyte retrieval using a catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normal HSG,
- •normal hormone levels,
- •normal over functions,
- •having normal uterine cavity and endometrial thickness determined by office hysteroscopy
- •no endometriosis (determined by transvaginal ultrasonography and / or diagnostic laparoscopy)
- •normal spermiogram result Recurrent Implantation Failure The inclusion criteria are;
- •1-The inclusion criteria of the working group are: 2-Failure of embryo transfer at least twice after high quality embryo transfer after 3-IVF treatment, 4-having normal hormone reserve (FSH <8 mIU / mL), 5-respond well to hormone stimulation (> 8 oocyte collection), 6-having normal uterine cavity and endometrial thickness determined by office hysteroscopy
排除标准
- 未提供
研究组 & 干预措施
RIF sperm chip (+)
Conventional IVF treatment and using sperm chip for sperm selection
干预措施: Sperm Chip (Procedure)
RIF sperm chip (-)
Conventional IVF treatment and using conventional sperm selection
干预措施: Sperm Chip (Procedure)
UEI Sperm Chip (-)
Conventional IVF treatment and using conventional sperm selection
干预措施: Sperm Chip (Procedure)
UEI Sperm Chip (+)
Conventional IVF treatment and using sperm chip for sperm selection
干预措施: Sperm Chip (Procedure)
结局指标
主要结局
Implantation Rate
时间窗: 36 month
Implantation rate is the number of gestational sacs observed on ultrasonog- raphy, divided by the number of embryos transferred.
Clinical Pregnancy Rate
时间窗: 36 month
Clinical pregnancy includes intrauterine gestation (pres- ence of a gestational sac on ultrasonography), ectopic preg- nancy, and miscarriage diagnosed by histology.Cycles with only a positive pregnancy test (biochemical pregnancy) are not considered to have a clinical pregnancy.
Live Birth Rate
时间窗: 36 month
A delivery is the birth of one or more infants, either living or not, after 20 weeks of gestation. A live birth is a delivery that results in at least one living infant
Abortion Rate
时间窗: 36 month
Pregnancy loss includes miscarriage and therapeutic abor- tion of a clinical intrauterine pregnancy occurring at %20 weeks of gestation.
次要结局
未报告次要终点
研究者
Murat Dogan
Principal İnvestigator
Acibadem University