Analyzing cervical mucus to identify markers for endometrial receptivity in infertility treatment
Biomarkers of Endometrial Receptivity: A Prospective Multicenter Study on Proteomic Biomarkers of Endometrial Receptivity in Cervical Mucus ( PRO BIOMER - CM )
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 476 (estimated) |
| Ages | N/A to 36 Years |
| Sex | Female |
| Sponsor | The Institute of Molecular and Translational Medicine, Czech Republic Academic / other |
| Locations | 3 sites (Brno, South Moravian and 2 other locations) |
| Trial ID | NCT04619524 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with genetic diseases, metabolic disorders, or polycystic ovary syndrome may not benefit from this study.
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 performed: While the approach of using proteomics to identify biomarkers is innovative, similar studies have shown promise in enhancing understanding of reproductive health.
Eligibility criteria
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 this trial is running
Brno, South Moravian and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.