Assessment of Implantation Potential of Embryos Cultured by Time-lapse Technology (Embryoscope) Before Transfer in In-vitro Fertilization (IVF) / Intracytoplasmic Sperm Injection (ICSI) Cycles: A Randomized Control Study.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- No.of top quality embryos produced in both the arms, study arm and control arm.
研究概览
简要总结
- Culture conditions of developing embryos are highly controlled in the Embryoscope and are monitored by Time-lapse videography to produce 3D images at different stages.This cannot be done under conventional culture conditions.
- The 3D images thus produced,are analysed with the help of Embryoviewer, a part of the Embryoscope,through latest software.
- Embryoviewer also identifies embryos for transfer, freezing and to be discarded.
详细描述
- There will be two arms of the study. The Study arm in which embryos of patients will be cultured in the Embryoscope. The control arm in which the embryos of patients will be cultured under conventional conditions.
- Embryos to be transferred will be identified by the Embryoviewer in the Study arm and the ones in the control arm will be identified by established subjective morphological criteria.
- Embryos with definite implantation potential will be transferred in both arms.
- Embryos not transferred will be frozen and/or discarded in both arms.
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
- 21 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of age 21-39 yrs.
- •Basal FSH < 12mIU/ml
- •Anterior mullerian hormone(AMH) > 1.0 ng/ML
- •Antral follicle count (AFC) > 8
- •Body mass index (BMI) < 35 mt2/kg
- •Estradiol (E2) < 50PG/ML
排除标准
- •Women with one ovary.
- •Women in whom both ovaries are not seen on ultrasonography.
- •Women with too small uterine cavity.
- •Women with history of recurrent pregnancy loss
- •Women with systemic lupus erythematosus (SLE), Nephrotic syndrome, Meyer Rocky Tansky Kustner Hammer(MRKH) syndrome,etc.
- •Human immunodeficiency virus (HIV) I and II positive women.
研究组 & 干预措施
Study Arm
Subjects would receive recombinant Follicle Stimulating Hormone (rFSH) by S.C. injection 150 - 225 IU/day for 9 days. The embryos of subjects would be cultured by time-lapse imagery technique (embryoscope) and analysis would be done using patients receive rFSH (Gonembryo viewer equipped with latest software.
干预措施: recombinant Follicle Stimulating Hormone (rFSH) (Drug)
Control Arm
Subjects would receive recombinant Follicle Stimulating Hormone (rFSH) by S.C. injection 150 - 225 IU/day for 9 days. The embryos of subjects would be cultured in conventional culture environment and analysis would be done using established subjective morphological criteria.
干预措施: recombinant Follicle Stimulating Hormone (rFSH) (Drug)
结局指标
主要结局
No.of top quality embryos produced in both the arms, study arm and control arm.
时间窗: 2 weeks
1. 4-cell embryos on day 2 of fertilization in both,Study arm and Control arm. 2. 8-cell embryos on day 3 of fertilization in both Study arm and Control arm. 3. Blastocyst embryos on day 5 or day 6 of fertilization in both Study arm and Control arm.
次要结局
- Clinical pregnancy(6 weeks after embryo transfer (ET))