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Application of Spectral Methods to Assess Gametes, Embryos, and Human Reproductive Capabilities

NCT06266169 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1064

Last updated 2024-02-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

making artificial intelligence based decisions of gamete, embryo and endometrial potential

The method of Raman spectroscopy is based on the registration of inelastic scattering of photons. Each compound has its own spectral pattern when using a certain type of monochromatic radiation (laser). With this method, it is possible to obtain metabolic fingerprints from the objects being studied. Luminescent spectroscopy is a type of spectroscopy used to register emission from objects that occurred after absorbing the exciting (primary) radiation. Spectrophotometry is the detection of radiation in the visible area of the spectrum. Raman spectroscopy is used for the spent medium and semen to build artificial intelligence model and make prognosis of function for each object. For endometrium, luminescent spectroscopy and spectrophotometry are used to build the model and test its clinical relevance

Sponsors & Collaborators

  • Family Planning Center of Women's Welfare Clinic #44 of Pushkin District

    lead OTHER_GOV

Principal Investigators

  • Alexey Gryaznov · Family planning center of SPB SBHI "Maternity welfare clinic" #44 of Pushkin district

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2024-02-28
Completion
2025-12-31

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06266169 on ClinicalTrials.gov