Analyzing cervical mucus to identify markers for endometrial receptivity in infertility treatment
Official title: Biomarkers of Endometrial Receptivity: A Prospective Multicenter Study on Proteomic Biomarkers of Endometrial Receptivity in Cervical Mucus ( PRO BIOMER - CM )
Run by The Institute of Molecular and Translational Medicine, Czech Republic · NCT04619524 · Data updated 2026-11-12
This study is testing if analyzing proteins in cervical mucus can help doctors find out which patients are more likely to have successful embryo transfers during infertility treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 36 Years |
| Sex | Women only |
| Enrollment | 476 (estimated) |
| Sponsor | The Institute of Molecular and Translational Medicine, Czech Republic Academic / other |
| Locations | 3 sites (Brno, South Moravian and 2 other locations) |
| Status | Recruiting |
| Started | May 1, 2018 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT04619524 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women under 37 years old who are undergoing IVF or embryo transfer and meet specific fertility criteria.
✕Probably not a fit
Patients with genetic diseases, metabolic disorders, or polycystic ovary syndrome may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study analyzes proteins from cervical mucus in patients undergoing infertility treatments, specifically during fresh or frozen embryo transfers. The goal is to identify potential new biomarkers that indicate endometrial receptivity, which is crucial for successful embryo implantation. By comparing the peptide profiles of pregnant and non-pregnant patients, researchers aim to enhance the understanding of endometrial receptivity and improve clinical decision-making regarding embryo transfers. The study utilizes advanced mass spectrometry techniques to detect protein variations that may correlate with receptivity defects.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for assessing endometrial receptivity, potentially increasing the success rates of IVF treatments.
How similar studies have gone: While the approach of using proteomics to identify biomarkers is innovative, similar studies have shown promise in enhancing understanding of reproductive health.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Brno University Hospital
Brno, South Moravian, Czechia Recruiting -
University Hospital Olomouc
Olomouc, Czechia Recruiting -
University Hospital Olomouc
Olomouc, Czechia Recruiting
Study contacts
- Study coordinator: Radovan Pilka, Prof.MD.PhD.
- Email: radovan.pilka@fnol.cz
- Phone: +420739329868
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Pentoxifylline to improve uterine lining and frozen embryo transfer outcomes
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Dual Trigger vs HCG Trigger for Final Maturation in Normal Responders
In normal responders undergoing ICSI cycles, this study tests whether using a dual trigger (GnRH agonist plus hCG) improves outcomes compared with the standard hCG trigger.
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Tadalafil to increase uterine lining and improve frozen embryo transfer success
This test sees if adding daily tadalafil to standard estrogen helps women with unexplained infertility using good-quality day‑5 frozen embryos get a thicker uterine lining and better transfer outcomes.
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This will test whether inhaling lavender oil twice daily can reduce anxiety, stress, and depression and improve quality of life for women awaiting IVF.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.