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临床试验/NCT06266169
NCT06266169Unknown不适用

Application of Spectral Methods to Assess the Potential of Gametes and Embryos, as Well as Human Reproductive Capabilities

Family Planning Center of Women's Welfare Clinic #44 of Pushkin District2 个研究点 分布在 2 个国家目标入组 1,064 人开始时间: 2023年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
1,064
试验地点
2
主要终点
Embryonic model clinical efficiency

研究概览

简要总结

Relevance of the research topic: At present, in the world, a kind of "plateau" in the efficiency of assisted reproductive technologies has been achieved, which ensures a birth rate of 30% per embryo transfer. At the same time, a relatively high (15-20%) and stable rate of miscarriages is preserved. Until now, no effective methods for assessing the potential of gametes and embryos, as well as human reproductive capabilities, have been offered. In these conditions, to increase the rate of births after IVF, clinicians have to increase the number of transferred embryos at a time, however, this leads to a sharp increase in complications of IVF, such as multiple pregnancy. In addition, until today, the clinical effectiveness of assessing the potential of endometrium using gene expression determination methods has not been shown. Therefore, to ensure the effectiveness and safety of infertility treatment, it is necessary to develop methods for predicting the potential of gametes and embryos, as well as human reproductive capabilities. For this purpose, the investigators assume to use Raman spectroscopy of the environment obtained from the objects of research, as well as fluorescent spectroscopy of endometrium. The objects of the research are gametes (spermatozoa) and embryos, used culture medium, endometrium. The subject of the study is the set of factors, that exists in the objects of research and their ability to determine the outcomes of infertility treatment.

详细描述

The goal of the planned work is to build a system for assessing and predicting the potential of gametes and embryos, as well as human reproductive capabilities, based on spectral data obtained from the objects of investigation, followed by prospective validation of the developed system. The study protocol consists of a retrospective and prospective stages. The task of the retrospective stage is to study gametes, embryos, and endometrium using the declared methods and build a machine learning model, determine the predictive capabilities of the obtained models. The task of the prospective stage is to determine the practical efficiency of applying models for making clinically significant decisions in infertility treatment with IVF. Hypothesis of the study: at the moment, a large number of approaches and protocols for deselecting and selecting embryos / gametes, assessing endometrial receptivity has been proposed. Approaches related to deselection are mainly based on determining the genetic constitution (aneuploidy) of the investigated object. However, there are no models linking such testing results and the outcome of infertility treatment with clinically significant effectiveness. There are many publications when, after transferring aneuploid embryos, pregnancy develops with a healthy fetus. It is known that the concordance of aneuploidy test results between the internal cell mass and trophoblasts is about 60%. Moreover, when using PGT-a, the birth rate among women with a single available blastocyst is reduced twice. Approaches related to selection, i.e. predicting a positive outcome of treatment, are built on morphological, morphometric, metabolic, and gene expression approaches. However, their effectiveness either has not been proven, or has (if it has) relatively low predictive importance. This is due to the fact that, from the point of modern views on reproductive biology, for the occurrence and development of successful pregnancy, it is necessary to combine factors that belong to gametes, embryos, and the maternal organism. Also, other undetectable technical or other circumstances may play a role in influencing the chance of ongoing pregnancy. Therefore, for effective prediction of a positive outcome, it is necessary to develop and apply complex models that take into account variables from different sources, from all parties involved. However, there will always be additional variability, caused by a series of unspecified or difficult to specify factors, which makes the task of such prediction quite challenging. In this connection, predicting a negative outcome of treatment (deselecting objects) seems more sensible, as it is entirely feasible for cases, where the cause of the negative outcome is attributable to this object (for example, the state of the embryo). This will not only optimize patient care protocols (for example, not to transfer obviously incapable to implant embryos), but also determine the possible cause of the negative outcome in each specific case, and in a population scale determine the share of variability of the phenomenon (development of ongoing pregnancy), which may be related to a specific object. The last one is necessary for adequate development and testing of new therapeutic and diagnostic methods

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Embryos: embryos that have reached the blastocyst stage
  • Sperm: samples used for IVF during infertility treatment
  • Endometrium: endometrial spectra in cases where an embryo transfer was performed into the uterus

排除标准

  • For all groups: ectopic pregnancy
  • Embryos: presence of only one blastocyst, and that embryo prognosed by the model as negative
  • Sperm: a cycle where less than 3 oocytes suitable for fertilization were obtained; total pathological fertilization; 60% or more immature oocytes at the time of fertilization registration

研究组 & 干预措施

intervention

Experimental

People undergoing IVF treatment with developed medical decisions support models

干预措施: making artificial intelligence based decisions of gamete, embryo and endometrial potential (Other)

control

No Intervention

People undergoing IVF treatment without developed medical decisions support models

结局指标

主要结局

Embryonic model clinical efficiency

时间窗: 14 weeks

Ongoing pregnancy rate per single embryo transfer (%)

Embryonic model performance

时间窗: 14 weeks

Positive predictive value for negative outcomes of single embryo transfers (%)

Gamete model performance

时间窗: 2 weeks

Positive predictive value for cycles with impaired embryo development in vitro (%)

Endometrial model performance

时间窗: 14 weeks

Positive predictive value for negative outcomes of single embryo transfers (%)

Endometrial model clinical efficiency

时间窗: 14 weeks

Ongoing pregnancy rate per single embryo transfer (%)

次要结局

未报告次要终点

研究者

发起方
Family Planning Center of Women's Welfare Clinic #44 of Pushkin District
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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