Study to Detect the Predictive Capacity of a Composite Biological Marker in the Success of Embryonic Implantation in Fertilization Treatments In Vitro (IVF): Seedchrony Pilot.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Intrauterine biomarker concentration on the day before embryo transfer
研究概览
简要总结
In Vitro Fertilization (IVF) success is below 40%, with Embryo Transfer the leading cause of IVF failure. This clinical investigation aims to evaluate if the levels of an intrauterine biomarker dissolved in the uterine fluid (alone or as a complex biological marker) can predict the outcome of embryo transfer.
详细描述
Seedchorny02 is an exploratory study, with blind evaluation by third parties, in a single center and without influencing clinical practice. The goal of this investigation is to evaluate if the levels of an intrauterine biomarker that is dissolved in the endometrial fluid can predict the outcome of embryo transfer, when measured the day before or on the day of embryo transfer.
80 IVF volunteers in a frozen embryo transfer cycle with high-quality day-five blastocysts are expected to be recruited. For intrauterine measurement, the investigational device Seedchrony RUO 02 will be used. Seedchorny RUO 02 has a microsensor integrated into the transfer catheter to measure the biomarker level in the uterine fluid entering the transfer catheter. Other patients' clinical variables and IVF cycle parameters (hormonal levels, ultrasound parameters, embryo quality grades, and transfer protocol) will also be collected.
Primary variable: Relationship between intrauterine dissolved biomarker concentration (alone or as a complex biological marker) and the outcome of the embryo transfer.
Notes: The intrauterine biomarker concentration is measured twice: the day before the transfer and on the transfer day. Complex biological marker refers to combining the concentration of the biomarker on both days and/or with other clinical variables of the patient/embryo.
The outcome of the embryo transfer is evaluated as:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •First IVF cycle patients
- •Patients who sign the informed consent form
- •Patients between 18 and 37 years old.
- •Patients BMI ≤ 30
- •Patients who have frozen blastocysts of good quality (grade A or B)
- •Patients with negative vaginal and endocervical cultures
- •Patients with an antimullerian hormone level greater than 1 ng/mL.
- •IVF patients with an endometrial thickness greater than 7mm with trilaminar pattern on the day of the pre-progesterone visit.
- •And who meets one of these conditions:
- •Not having had a previous embryo transfer.
- •Have failed only one embryo transfer
排除标准
- •Patients with seminal data of the couple with severe oligozoospermia (sperm concentration <1 million sperm per ml) or azoospermia (absence of sperm in the ejaculate)
- •Patients diagnosed with at least one of the following uterine pathologies: endometriosis, cancer, malformations, untreated polyps, or submucous fibroids.
- •Patients diagnosed with at least one of the following medical pathologies: Polycystic ovary syndrome (PCOS), insulin-dependent diabetes mellitus, Cushing's syndrome, uncorrected thyroid dysfunction, hepatic and/or renal insufficiency, a pathology that contraindicates ovarian stimulation and/or gestation, antiphospholipid syndrome, and autoimmune disease.
- •Patients who are currently taking any medication other than contraceptive treatments, which may interfere with fertility or menstrual cycle regulation.
- •Evidence of drug, tobacco, or alcohol abuse or dependence according to medical history or information provided by the patient.
- •Inadequate understanding (oral and written) of the Spanish language.
研究组 & 干预措施
Measurement
Intrauterine biomarker will be measured twice in all enrolled patients during the frozen embryo transfer cycle: on the day before embryo transfer and on the day of embryo transfer.
干预措施: Seedchrony (Device)
结局指标
主要结局
Intrauterine biomarker concentration on the day before embryo transfer
时间窗: one day
The Seedchrony probe is coupled to the transfer catheter and placed in the uterine cavity. The probe measures the biomarker concentration in the fluid entering the catheter.
Intrauterine biomarker concentration on the embryo transfer day
时间窗: one day
The Seedchrony probe is coupled to the transfer catheter and placed in the uterine cavity. The probe measures the biomarker concentration in the fluid entering the catheter.
次要结局
- User experience and device safety in the clinical environment(12 months)
- Biochemical Pregnancy(10-14 days after embryo transfer)
- Ongoing Pregnancy(6 weeks after embryo transfer)
- Clinical Pregnancy(4 weeks after embryo transfer)
- Evaluate the patient's experience during measurements.(two days (day before embryo transfer and on the transfer day))