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

NCT06266169 | Recruiting DMC

• 1 other identifier: fpc-2023-ivf-01
• Study Type: interventional
• Target: 1,064
• Locations: 1 country
• Sites: 1

Brief 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

Infertility

Outcome Measures

Primary Outcomes (5)

• Embryonic model performance

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

  14 weeks

• Gamete model performance

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

  2 weeks

• Endometrial model performance

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

  14 weeks

• Embryonic model clinical efficiency

  Ongoing pregnancy rate per single embryo transfer (%)

  14 weeks

• Endometrial model clinical efficiency

  Ongoing pregnancy rate per single embryo transfer (%)

  14 weeks

Study Arms (2)

intervention

EXPERIMENTAL

People undergoing IVF treatment with developed medical decisions support models

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

control

NO INTERVENTION

People undergoing IVF treatment without developed medical decisions support models

Interventions

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

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

intervention

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Family planning center

Saint Petersburg, Pushkin, 196608, Russia

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Alexey Gryaznov

  Family planning center of SPB SBHI "Maternity welfare clinic" #44 of Pushkin district

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexey Gryaznov

CONTACT

+7(812)414-57-11; libra19831010@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 20, 2024
• Study Start: September 20, 2023
• Primary Completion: February 28, 2024
• Study Completion: December 31, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)