A Prospective, Single-center, Randomized, Two-arm, Interventional Study to Evaluate the Implantation Rate of Embryos Selected on the Basis of Morphology and Granulocyte-Colony Stimulating Factor (G-CSF) Concentration in the Ovarian Follicular Fluid (FF) - FF G-CSF - Compared to the Implantation Rate of Embryos Selected on the Basis of Morphology Alone When Elective Single Embryo Transfer (SET) of a Fresh Embryo is Performed on Day 2/3 After Oocyte Retrieval
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Percentage of successful implantations
研究概览
简要总结
Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women at least 18 years old at the time of Informed Consent.
- •Able to understand and voluntarily sign an Informed Consent form approved by the relevant Independent Ethics Committee (IEC) governing the site.
- •First or second fresh Assisted Reproductive Technology (ART) cycle attempt (since last successful implantation, if any).
- •Eligible for elective SET of fresh embryo on Day 2/
- •Elective SET is defined as a transfer for which there is more than one embryo in the same morphological ("best") category as that of the selected embryo.
排除标准
- •Presence or history of ovarian endometriotic cyst.
- •Presence or history of diagnosed severe endometriosis (i.e. stage IV of the revised American Fertility Society classification for endometriosis).
- •Hormonal, functional, anatomical and/or other abnormalities potentially increasing the risk of miscarriage and/or ectopic pregnancy as judged by the Investigator and determined by medical history and clinical laboratory. This includes, but is not limited to, uncontrolled diabetes mellitus, uncontrolled thyroid disease, alcoholism, drug abuse, abnormal uterine cavity etc.
- •History of two or more consecutive miscarriages.
- •Known history of human immunodeficiency virus, Hepatitis C virus and/or Hepatitis B virus infection.
- •The subject has other serious or acute conditions that, in the Investigator's opinion, would preclude her participation in the study.
- •Need for preimplantation genetic diagnosis/screening.
- •Use of time-lapse embryo imaging
- •Participating in oocyte donation procedure.
- •Participation in any interventional drug clinical investigation within 2 months
- •Dependency on sponsor or investigator (e.g. co-worker or family member).
研究组 & 干预措施
Diafert
The embryo to be transferred is selected on the basis of both morphological assessment performed on Day 2 or 3 and FF G-CSF concentration. FF G-CSF concentration will be measured with the Diafert® immunoassay.
干预措施: Daifert (Device)
Control Group
The embryo to be transferred is selected on the basis of morphological assessment performed on Day 2 or 3.
干预措施: Control Group (Other)
结局指标
主要结局
Percentage of successful implantations
时间窗: At Week 6
The percentage of successful implantation 6 weeks after oocyte retrieval (±3 days), i.e. at approximately 8 weeks gestational age (±3 days) or 8 weeks of amenorrhea (± 3 days), in each group (Control and Interventional groups), overall and within each morphological embryo category, when elective Single Embryo Transfer (SET) is performed on Day 2 or 3. Successful implantation is defined as the presence in the uterus of at least one gestational sac with fetal heart activity identified on ultrasound.
次要结局
- Percentage of live births(Approximately Week 40 (pregnancy outcome))