IVFBIOMERNCT04619524
Biomarkers of Endometrial Receptivity
A study testing Cervical mucus will be collected from patients undergoing IVF and Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryos in people with IVF and Infertility Treatment, run by The Institute of Molecular and Translational Medicine, Czech Republic at 3 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 36 years, women only
- Conditions the study is for
- IVF, Infertility Treatment, Fertility Disorders
- What is being tested?
- Cervical mucus will be collected from patients undergoing IVF and Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryos
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 476 participants
- Where
- 3 sitesCzechia
- Study dates
- 1 May 2018to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 25Show fewer
- 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
- 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
Who cannot join
- 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)
Show all 33Show fewer
- 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)
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia3 sites, 3 recruiting
- Recruiting
Brno University Hospital
Brno, South Moravian, 62500
Igor Crha, MD, PhD, +420728159163, crha.igor@fnbrno.cz
- Recruiting
University Hospital Olomouc
Olomouc, 77900
Petr Dzubak, MD, PhD, +420 585632150, petr.dzubak@upol.cz
Marian Hadjuch, MD, PhD, +420 585632082, marian.hajduch@upol.cz
- Recruiting
University Hospital Olomouc
Olomouc
Radovan Pilka, Prof.MD., +420739329868, radovan.pilka@fnol.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- IVF, Infertility Treatment, Fertility Disorders, Embryo Transfer
- Being tested
- Cervical mucus will be collected from patients undergoing IVF, Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryos
- Keywords
- cervix, mucus, endometrium, receptivity, biomarker, proteomics, infertility, in-vitro, fertilisation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical mucus will be collected from patients undergoing IVFDiagnostic test
Patients undergoing hormonal stimulation for IVF will be sampled for cervical mucus.
Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryosDiagnostic test
Patients undergoing hormonal substitution for transfer of cryopreserved embryos will be sampled for cervical mucus.
| Study group | Role | What they receive |
|---|---|---|
| A: Patients undergo cycle with the transfer of fresh embryos | Experimental | 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. Receives: Diagnostic Test: Cervical mucus will be collected from patients undergoing IVF |
| B: Patients undergo cycle with the transfer of frozen embryos | Experimental | In study group B cervical mucus will be sampled from patients undergoing treatment cycles with the transfer of cryopreserved embryos. Receives: Diagnostic Test: Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 months
Secondary outcomes (2)
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.
Measured: 48 months
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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 May 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Olomouc, Brno University Hospital
- Responsible party
- Sponsor
- Investigators
- Marian Hajduch, MD.PhD., Study director, Palacky University in Olomouc, Faculty of Medicine and Dentristry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619524
- Sponsor's protocol ID
- 4616-27870
- Acronym
- BIOMER
- Status last verified
- Mar 2026
- First submitted
- 2 Nov 2020
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Endometrial Receptivity: A Prospective Multicenter Study on Proteomic Biomarkers of Endometrial Receptivity in Cervical Mucus ( PRO BIOMER - CM )
- ClinicalTrials.gov ID
- NCT04619524
- Acronym / sponsor ID
- BIOMER / 4616-27870
- Conditions
- IVF, Infertility Treatment, Fertility Disorders, Embryo Transfer
- Keywords
- cervix, mucus, endometrium, receptivity, biomarker, proteomics, infertility, in-vitro
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- The Institute of Molecular and Translational Medicine, Czech RepublicUniversity, hospital or other
- Collaborators
- University Hospital Olomouc, Brno University Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Patients undergo cycle with the transfer of fresh embryos | Experimental | Diagnostic Test: Cervical mucus will be collected from patients undergoing IVFIn 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 | Experimental | Diagnostic Test: Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryosIn study group B cervical mucus will be sampled from patients undergoing treatment cycles with the transfer of cryopreserved embryos. |
Who may qualify
- Ages
- Up to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical mucus will be collected from patients undergoing IVFPatients undergoing hormonal stimulation for IVF will be sampled for cervical mucus. | Diagnostic test | A: Patients undergo cycle with the transfer of fresh embryos |
| Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryosPatients undergoing hormonal substitution for transfer of cryopreserved embryos will be sampled for cervical mucus. | Diagnostic test | B: Patients undergo cycle with the transfer of frozen embryos |
Primary outcome
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.
2 secondary outcomes
Comparison of the protein analysis between the pregnant and not pregnant patients
Time frame: 48 months
Detection of the new endometrial receptivity biomarkers.
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marian Hajduch, MD.PhD. study director
Palacky University in Olomouc, Faculty of Medicine and Dentristry
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical mucus will be collected from patients undergoing IVF and Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryos in people with IVF and Infertility Treatment, run by The Institute of Molecular and Translational Medicine, Czech Republic at 3 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radovan Pilka, Prof.MD.PhD. (+420739329868, radovan.pilka@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mass spectrometer analysis of the proteins from cervical mucus (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.