Biomarkers of Endometrial Receptivity (BIOMER)

March 19, 2026 updated by: The Institute of Molecular and Translational Medicine, Czech Republic

Biomarkers of Endometrial Receptivity: A Prospective Multicenter Study on Proteomic Biomarkers of Endometrial Receptivity in Cervical Mucus ( PRO BIOMER - CM )

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

476

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Olomouc, Czechia
        • Recruiting
        • University hospital Olomouc
        • Contact:
      • Olomouc, Czechia, 77900
        • Recruiting
        • University hospital Olomouc
        • Contact:
        • Contact:
    • South Moravian
      • Brno, South Moravian, Czechia, 62500
        • Recruiting
        • Brno University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 36 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria - Arm A - stimulated cycle:

  • 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
  • normal responder
  • fewer than three failed cycles of assisted reproduction treatment, including fresh IVF/ intracytoplasmic sperm injection (ICSI) embryo transfer cycles and/or frozen-thawed embryo transfer cycles
  • sperm obtained through ejaculation
  • spermiogram more than 5 million sperm/mL
  • BMI 19-29 kg/m2
  • follicle stimulating hormone (FSH) < 10 IU/L on the third day
  • basal antral follicle count of 5-15
  • undergoing the same routine gonadotrophin-releasing hormone agonist (GnRHa) long depot or gonadotrophin-releasing hormone antagonist (GnRH-ant.) protocol
  • informed consent

Exclusion Criteria - Arm A - stimulated cycle:

  • genetic disease
  • metabolic and/or endocrine disorders
  • polycystic ovary syndrome (defined by the Rotterdam criteria)
  • women with prior diagnosis of endometriosis or adenomyosis
  • previous gynecological/pelvic surgery except for salpingectomy
  • repeated spontaneous abortions (two or more)
  • previously less than 5 oocytes and/or serum anti-Mullerian hormone value < 1.0 mIU/ml or more than 20 oocytes, milli-International unit (mIU)
  • previous ovarian hyperstimulation syndrome (OHSS)
  • presence of any structural abnormality of the reproductive system
  • donor oocyte cycles
  • severe male factor infertility < 5 million sperm/mL
  • low response to stimulation
  • endometrium < 8 mm at the day of human chorionic gonadotropin (hCG) or ET
  • number of retrieved oocytes 5 - 20
  • low fertilization capacity (rate of fertilization < 20% and late ICSI following IVF fertilization failure)
  • OHSS
  • IVF cycle cancelled before ET
  • other than easy one high-quality blastocyst transfer (at least grade 3BB)

Inclusion criteria - Arm B - substituted cycle:

  • 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
  • normal responder at stimulation
  • fewer than three failed cycles of assisted reproduction treatment, including fresh IVF/ intracytoplasmic sperm injection (ICSI) embryo transfer cycles and/or frozen-thawed embryo transfer cycles
  • sperm obtained through ejaculation
  • spermiogram more than 5 million sperm/mL
  • BMI 19-29 kg/m2
  • FSH < 10 IU/L on the third day
  • undergoing the same routine estrogen/progesterone substituted cycle
  • informed consent

Exclusion criteria - Arm B - substituted cycle:

  • genetic disease
  • metabolic and/or endocrine disorders such as diabetes, metabolic syndrome, and thyroid disorders
  • polycystic ovary syndrome (defined by the Rotterdam criteria), hyperprolactinaemia
  • women with prior diagnosis of endometriosis or adenomyosis
  • previous gynecological/pelvic surgery except for salpingectomy
  • repeated spontaneous abortions (two or more)
  • previously less than 5 oocytes and/or serum anti-Mullerian hormone value < 0.5 mIU/ml in the stimulated cycle
  • previous OHSS
  • presence of any structural abnormality of the reproductive system
  • severe male factor infertility < 5 million sperm/mL in the stimulated cycle
  • number of retrieved oocytes 5 - 20 in the stimulated cycle
  • low fertilization capacity (rate of fertilization < 20% and late ICSI following IVF fertilization failure)
  • endometrium less than 8 mm at the day of thawing and transfer indication
  • thawed blastocyst cycle cancelled before ET
  • other than easy one best quality frozen/thawed blastocyst transfer (at least grade 3BB)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: Patients undergo cycle with the transfer of fresh embryos
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.
Diagnostic test: Cervical mucus will be collected from patients undergoing IVF
Patients undergoing hormonal stimulation for IVF will be sampled for cervical mucus.
Experimental: B: Patients undergo cycle with the transfer of frozen embryos
In study group B cervical mucus will be sampled from patients undergoing treatment cycles with the transfer of cryopreserved embryos.
Diagnostic test: Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryos
Patients undergoing hormonal substitution for transfer of cryopreserved embryos will be sampled for cervical mucus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mass spectrometer analysis of the proteins from cervical mucus
Time Frame: 48 months
Highly sensitive mass analysis of the proteins from cervical mucus on Thermo Orbitrap Elite instrument for all collected samples.
48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the protein analysis between the pregnant and not pregnant patients
Time Frame: 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.
48 months
Detection of the new endometrial receptivity biomarkers.
Time Frame: 48 months
Proteomic endometrial receptivity biomarkers will be detected based on the analysis of measured data in relation to the successful implantation.
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Collaborators

Brno University Hospital
University Hospital Olomouc

Investigators

  • Study Director: Marian Hajduch, MD.PhD., Palacky University in Olomouc, Faculty of Medicine and Dentristry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4616-27870

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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