NCT01058603Unknown3 期
Multicentre, Randomised, Controlled Clinical Study on the Efficacy in Terms of Clinical Pregnancy Rate of 1 Embryo Transfer at Day 5 After Co-culture on Autologous Endometrial Cells(ENDOCELL®) Versus 1 Embryo Transfer at Day 3 After Culture on Conventional Medium.
Laboratoires Genévrier2 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 720
- 试验地点
- 2
研究概览
简要总结
The aim of this study is to demonstrate the efficacy of a single embryo transfer at blastocyst stage (Day 5) after co-culture on Autologous Endometrial Cell Culture (AECC) versus transfer of a single embryo at Day 3 after culture in conventional medium. Efficacy will be assessed in terms of clinical pregnancy rate 5 to 8 weeks after embryo transfer.
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 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 and ≤ 36
- •Undergoing ovarian stimulation for an In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI)
- •Having experienced no more than 1 Embryo Transfer failure
- •With basal FSH level ≤ 12 IU/l within the 6 months prior to the study
- •Endometrial biopsy during the menstrual cycle preceding the ovarian stimulation (6 to 12 days after a documented ovulation)
- •Negative serology for HIV 1 and 2, hepatitis B and C, HTLV 1 and 2, syphilis
排除标准
- •Hypersensitivity to one of the culture media components
- •Oocyte donation, sperm donation
- •Thawed embryos transfer
- •Women with endometriosis grade III and IV, chronic endometritis, hydrosalpinx, polycystic ovary, amenorrhoea, anovulation, uterus with malformation, uncontrolled prolactinaemia, uterine synechia, uterine fibroma, women exposed to distilbene, uterine polyps
- •Women affected by pathologies associated with any contraindication of being pregnant
- •Abnormal gynaecologic bleeding of undetermined origin
- •Uncontrolled thyroid (TSH dosage) or adrenal dysfunction
- •Neoplasias, any pathologies of the endometrium or the cervix
研究者
研究点 (2)
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