Assessment of Transfer Direct System (TDS) as a New Method for Embryo Transfer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- Safety of TDS in comparison with conventional transfer
研究概览
简要总结
Infertility is defined as the inability to conceive within a year of unprotected intercourse. Infertility affects one in six couples and represents a public health problem causing feelings of helplessness, depression, and anxiety in both women and men worldwide. Despite the desire to become parents, up to 50% of infertile couples do not seek medical treatment, and 50-60% abandon treatment after two or three failed in vitro fertilization (IVF) cycles, even when the procedure is covered by insurance or public health. There are multiple reasons for this discontinuation; however, after removing cost considerations, psychological stress and poor prognoses represent the main reasons for stopping treatment.
Clinical infertility treatments are generally ineffective. Success remains poor even with IVF, as evidenced by current live birth rates (LBRs) of only ~30% per initiated cycle. The primary challenge in ART lies mainly in the embryo implantation process, which remains the most significant bottleneck in IVF success, accounting for over 50% of ART failures.
Embryo transfer (ET), the final step in IVF, has seen little technological advancement since its inception over four decades ago. The procedure is typically performed transcervically and largely relies in tactile sensation and operator's experience. Although a simple procedure, several potential negative factors may be linked to the low number of IVF pregnancies, including variations in catheter placement, the risk of uterine contractions and lack of control of intrauterine pressure and embryo placement can result in up to 15% of the transferred embryos being inadvertently expelled from the uterus. Therfore, ET's success is highly dependent on non-controllable variables as well as the skill and experience of the operator, resulting in significant inter-operator variability.
Premium Fertility team has developed a controlled embryo transfer system - the Transfer Direct System (TDS) - that incorporates a visualization system to guide embryo delivery with the help of a fully automated microfluidic system that avoids initial phases of apposition and adhesion of implantation of human embryos. This technique places the embryo directly in the endometrial tissue, thereby minimizing the effects of embryo expulsion and potentially offering significant advantages such as the ability to visualize the uterine cavity through an endoscope at the time of embryo transfer and control the mechanics of the injection procedure to increase precision.
详细描述
Embryo transfer represents the most critical step in IVF; however, this highly operator-dependent procedure has not evolved significantly since the first description of its use. In this study, Premium Fertility investigators propose a new method of embryo transfer using high-precision automated injection of embryos into the uterus to minimize expulsion, facilitate implantation, and minimize inter- and intra-operator variability. If successful, TDS will provide for safe and consistent embryo transfer and will be transformative in the most critical procedure of fertility treatments, potentially increasing the success rates of such therapies.
The TDS is a medical device used in embryo transfer processes in patients undergoing ART, and it's a semi-automated piece of medical equipment designed to inject an embryo or a fertilized ovum into the maternal uterine endometrium through the lumen of the female reproductive system. The system is made up of two instruments and different consumables:
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CEC device: an instrument embryologists use to collect the human embryo for transfer and performs the functions of wetting the needle and collecting the embryo. This instrument does not interact with the patient.
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CET device: an instrument gynecologists use to inject an embryo into the maternal uterine endometrium. This instrument is placed in the embryo transfer room and has an umbilical cable controlling the TD needle that ultimately injects the embryo in the endometrial tissue. None of the CET components come into direct or indirect contact with the patient.
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Consumables:
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TD needle: Performs embryo collection in the embryology laboratory and embryo injection into the maternal uterine endometrium.
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TD catheter: Used to introduce the TD needle and TD camera through the lumen of the female reproductive system during the transfer; the TD catheter is fixed using the TD speculum lock to keep the needle in stable position during the automatic injection of the embryo. It has a membrane tip at the distal end.
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TD speculum lock: Fixing the TD catheter to the speculum allows TD catheter placement; manual blocking when it contacts the endometrium ensures a fixed position of the catheter and needle for embryo injection.
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TD camera: Video and lighting using fiber optics improve the visibility of the vaginal mucosa and the location of the endometrium surface for correct implantation.
The aim of the study is to assess whether the medical device - Transfer Direct System (TDS) - is a safe and effective method for embryo transfer.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients whose written informed consent is obtained, approved by the Ethics Committees for Investigation with Medicinal Products (ECRmp) after being duly informed of the nature of their disease and after voluntarily accepting the treatment program, knowing the potential risks, benefits, and inconveniences.
- •Patients who are going to undergo ART with a SET and have at least one vitrified euploid blastocyst with PGT-A (Preimplantation Genetic Test for the detection of Aneuploidy).
- •Women of reproductive age between 18 and 50 years (both inclusive)
- •Body mass index (BMI): <30 kg/m2
- •Absence of adenomyosis and endometriosis
- •Uterus without pathologies that can contraindicate the transfer or may hinder implantation (e.g., polyps, fibroids that come into contact with the cavity, or Asherman syndrome) or without a history of thin endometrium or irregular patterns in thin endometrial preparations.
- •Absence of immune pathologies (e.g., lupus) that could endanger the health of the patient.
- •Easy transfer test or history of embryo transfer without difficulty or factors that indicate that the transfer is easy.
排除标准
- •Difficult or very painful transfer tests.
- •Pathologies of an oncological nature.
- •The existence of serious or uncontrolled bacterial, fungal, or viral infections that, in the opinion of the principal investigator, may interfere with the patient's participation in the study or the evaluation of its results.
- •Other circumstances or difficulties that, in the opinion of the investigator, may pose a risk to the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, such as a history of severe preeclampsia without assessment by the obstetric team, psychiatric pathologies without prior assessment by the psychiatrist, uncontrolled or destabilized cardiac pathologies.
研究组 & 干预措施
Embryo transfer with Transfer Direct System (TDS)
The trial has a single assignment group aimed at patients of reproductive age who attend the clinic with a desire for a child and undergo Assisted Reproduction Treatment (ART) with an euploid single embryo transfer (SET) after corresponding hormone replacement therapy (HRT) has been carried out.
干预措施: Transfer Direct System (TDS) (Device)
结局指标
主要结局
Safety of TDS in comparison with conventional transfer
时间窗: From enrollment to final study visit at 8-10 weeks of pregnancy
Incidence, prevalence and frequency of adverse events.
次要结局
- Efficacy and non-inferiority of TDS(up to 8-10 weeks)
- pregnancy rate(From enrollment to final study visit at 8-10 weeks of pregnancy)
- ongoing gestation rate(From enrollment to final study visit at 8-10 weeks of pregnancy)
- miscarriage rate(From enrollment to final study visit at 8-10 weeks of pregnancy)