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Biomarkers of Endometrial Receptivity

ConditionsIVFInfertility TreatmentFertility DisordersEmbryo Transfer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeUp to 36
SponsorThe Institute of Molecular and Translational Medicine, Czech Republic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

female aged less than 37 years (maximally 36y + 364d)

no smoker

normal menstrual cycles lasting between 25 to 35 days

had been infertile for less than five years

Disqualifiers

genetic disease

metabolic and/or endocrine disorders

polycystic ovary syndrome (defined by the Rotterdam criteria)

women with prior diagnosis of endometriosis or adenomyosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cervical mucus will be collected from patients undergoing IVF

    Diagnostic test

    Patients undergoing hormonal stimulation for IVF will be sampled for cervical mucus.

  • Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryos

    Diagnostic test

    Patients undergoing hormonal substitution for transfer of cryopreserved embryos will be sampled for cervical mucus.

Treatment groups

476 Participants
are divided into 2 treatment groups
Group A: A: Patients undergo cycle with the transfer of fresh embryosExperimental treatment 1 intervention
Group B: B: Patients undergo cycle with the transfer of frozen embryosExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mass spectrometer analysis of the proteins from cervical mucus

Highly sensitive mass analysis of the proteins from cervical mucus on Thermo Orbitrap Elite instrument for all collected samples.

Time frame
48 months

Secondary outcomes

1

Comparison of the protein analysis between the pregnant and not pregnant patients

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.

Time frame
48 months
2

Detection of the new endometrial receptivity biomarkers.

Proteomic endometrial receptivity biomarkers will be detected based on the analysis of measured data in relation to the successful implantation.

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Institute of Molecular and Translational Medicine, Czech Republic

Lead sponsor

University Hospital Olomouc

Collaborator

Brno University Hospital

Collaborator

Source ClinicalTrials.gov
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