protocolSection identificationModule nctId: NCT06266169, orgStudyIdInfo id: fpc-2023-ivf-01, briefTitle: Application of Spectral Methods to Assess Gametes, Embryos, and Human Reproductive Capabilities, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Family Planning Center of Women's Welfare Clinic #44 of Pushkin District, class: OTHER_GOV, descriptionModule briefSummary: 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., conditionsModule conditions: Infertility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: For the retrospective (observational) stage of the study:Embryos: 424 samples of the culture medium used from individually cultured blastocysts that were fresh and frozen before transferring a single embryo from the institution's internal biobank. Each sample is attributed based on the presence or absence of progressing pregnancy after transfer at 12-14 weeks.Semen: 340 samples of sperm from the internal biobank of couples undergoing ICSI, each sample is attributed based on the success or failure of the embryological stage.Endometrium: 300 samples of luminescent and visible spectra of patients' endometrium undergoing embryo transfer, each sample is attributed based on the presence or absence of ongoing pregnancy after transfer.For the prospective (interventional) stage of the study:For each object of study, the size of the dataset for prospective testing can only be determined after passing the observational part of the study., primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1064, type: ESTIMATED, armsInterventionsModule interventions name: making artificial intelligence based decisions of gamete, embryo and endometrial potential, outcomesModule primaryOutcomes measure: Embryonic model performance, primaryOutcomes measure: Gamete model performance, primaryOutcomes measure: Endometrial model performance, primaryOutcomes measure: Embryonic model clinical efficiency, primaryOutcomes measure: Endometrial model clinical efficiency, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: Family planning center, status: RECRUITING, city: Saint Petersburg, state: Pushkin, zip: 196608, country: Russian Federation, contacts name: Alexey Gryaznov, role: CONTACT, phone: +7(812)414-57-09, email: libra19831010@mail.ru, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False