Improvement of Live Babies Rates After ICSI, Using cpFT: Multicenter Prospective Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Live birth rate after the first embryo transfer
研究概览
简要总结
Demonstrate the improvement of the live births rate after ICSI by supplementing the pre-ICSI incubation medium of oocytes and that of preimplantation embryos with cpFT at the 1st embryo transfer for women under 37 years old.
详细描述
Supplementation of the incubation medium with cFEE should improve the implantation rate and ART outcome.
As in France ICSI is widely used to achieve good fertilization rates, we decided to use ICSI to fertilize the egg, and the peptide:
- to improve chromosome segregation during meiosis, and
- to improve in vitro embryogenesis after ICSI. Hence the protocol includes an oocyte preincubation step prior to ICSI and a co incubation of the embryo with the molecule during blastocyst formation.
Hence our protocol includes:
- - a preincubation of the decoronized oocytes with the peptide prior to ICSI, and
- - a coincubation of the developing embryo with the molecule.
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
- Double (Participant, Investigator)
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
- •Couples eligible for a attempt at Assisted Reproduction (AMP).
- •Couples asking for Assisted Reproductive Technology, and requiring an ICS procedure.
- •Women aged 18 to 36 inclusive.
- •Men aged 18 to 58 inclusive
- •Use of CSCM-C culture medium from Biocare / Irvine, exclusively.
- •People affiliated to a Social Security scheme
排除标准
- •Lack of consent
- •Early menopause.
- •Couples under IVF or Intra Uterine Insemination treatment.
- •People unable to follow protocol visits in France.
- •Couple with a contraindication to treatment with ART.
- •Women with a contraindication to treatment with ART or an associated pathology such as: hypertension, risk of eclampsia, family genetic problems, diabetes, uterine partitions, synechiae adhesions, adenomyosis or any other contraindication judged as such by the investigator.
- •ART with donation of gametes or embryos.
- •Participant under guardianship or guardianship
研究组 & 干预措施
Fertiline group
Treated by supplementation of the culture medium with the molecule.
干预措施: Cyclic peptide Fertiline (Drug)
结局指标
主要结局
Live birth rate after the first embryo transfer
时间窗: 54 months after the first randomization
Demonstration of the improvement in the rate of live births after ICSI by supplementing the pre-ICSI incubation medium of oocytes and that of preimplantation embryos with cpFT (1µM) during the 1st embryo transfer in women under 37 years of age.
次要结局
- Level of Metaphase II oocytes(During the randomization period, which is 42 months.)
- Quality of the embryonic culture(42 months after the first randomization)
- Evaluation of the kinetics of embryonic development when possible.(42 months after the first randomization)
- Embryonic quality at the blastocyst stage(Day 5-6 after ICSI)
- Quality of the embryos after vitrification(Day 5-6 after ICSI)
- Implantation rate with positive Beta hCG after transfer(54 months after the first randomization)
- Clinical pregnancy rates with cardiac activity(until 54 months after the first randomization)
- The rate of miscarriages per pregnancy(until 54 months after the first randomisation)
- rate of abnormality on morphological ultrasounds(51 months after the first randomisation)
- rate of neonatal abnormality(54 months after the first randomisation)
- children's development(72 months after the beginning of the study)
- Weight of the placenta; Study of DNA, RNA, Western-Blot, Methylation, histological study(54 months after the first randomization)