Biomarkers of Endometrial Receptivity
- Conditions
- Infertility TreatmentFertility DisordersIVFEmbryo Transfer
- Interventions
- Diagnostic Test: Cervical mucus will be collected from patients undergoing IVFDiagnostic Test: Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryos
- Registration Number
- NCT04619524
- Lead Sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Brief Summary
Analysis of proteins from cervical mucus will be done in patients undergoing infertility treatment (fresh or frozen embryo transfer). Cervical mucus will be analysed for potential new biomarkers of endometrium receptivity. Comparison of the peptide spectrum will be done for the pregnant and not pregnant patients.
- Detailed Description
Successful implantation depends on synchronization between a normal functional embryo at the blastocyst developmental stage and a receptive endometrium. The endometrium is receptive to blastocysts during a spatially and temporally restricted time window called the "window of implantation". Failure of the endometrium to attain receptivity is one cause of infertility, and this is not currently assessed during infertility workup due to a lack of reliable markers for receptivity. Better tests are required to assist the clinician with the decision when to defer a transfer and to freeze all embryos. Proteomics, or the analysis of the proteins in any sample, provides physiologically relevant information, since there are many regulatory steps between the transcriptome and functional proteins. Uterine fluid is a protein-rich histotroph that contains, among other components, secretions from the endometrial glands and cleavage products of both the secreted proteins and the glycocalyx. The aim of this study is to assess the highly sensitive mass spectrometer analysis of the proteins from cervical mucus for the detection of defects in endometrial receptivity and search for new endometrial receptivity biomarkers.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 476
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A: Patients undergo cycle with the transfer of fresh embryos Cervical mucus will be collected from patients undergoing IVF In study group A the cervical mucus will be collected from patients undergoing the in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI)/embryo transfer (ET) cycle with the transfer of fresh embryos. B: Patients undergo cycle with the transfer of frozen embryos Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryos In study group B cervical mucus will be sampled from patients undergoing treatment cycles with the transfer of cryopreserved embryos.
- Primary Outcome Measures
Name Time Method Mass spectrometer analysis of the proteins from cervical mucus 48 months Highly sensitive mass analysis of the proteins from cervical mucus on Thermo Orbitrap Elite instrument for all collected samples.
- Secondary Outcome Measures
Name Time Method Comparison of the protein analysis between the pregnant and not pregnant patients 48 months Comparison of the protein analysis (qualitative and quantitative) will be done between the pregnant and not pregnant patients. Pregnant patients will be followed-up until child delivery.
Detection of the new endometrial receptivity biomarkers. 48 months Proteomic endometrial receptivity biomarkers will be detected based on the analysis of measured data in relation to the successful implantation.
Trial Locations
- Locations (2)
Brno University Hospital
🇨🇿Brno, Jihomoravsky Kraj, Czechia
University Hospital Olomouc
🇨🇿Olomouc, Czechia