IVF Clinical Trial
— BIOMEROfficial 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.
Status | Recruiting |
Enrollment | 476 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 36 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Czechia | Brno University Hospital | Brno | Jihomoravsky Kraj |
Czechia | University Hospital Olomouc | Olomouc | |
Czechia | University Hospital Olomouc | Olomouc |
Lead Sponsor | Collaborator |
---|---|
The Institute of Molecular and Translational Medicine, Czech Republic | Brno University Hospital, University Hospital Olomouc |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 48 months | |
Secondary | 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. | 48 months | |
Secondary | 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. | 48 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05969574 -
Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
|
||
Completed |
NCT04778358 -
Higher Dose of Rekovelle in Oocyte Donors
|
Phase 2 | |
Completed |
NCT04052464 -
The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
|
||
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Suspended |
NCT04669652 -
Evaluating Piezo-ICSI. - The EPI Study.
|
N/A | |
Completed |
NCT04524026 -
RIOTC: Reducing the Impact of Ovarian Stimulation. Novel Approaches to Luteal Support in IVF-Study 2
|
Phase 2 | |
Recruiting |
NCT05981898 -
Opt-IVF Multi-center Trial 2 Including All Protocols
|
N/A | |
Recruiting |
NCT05737381 -
Quality of Human Embryos in IVF, Culturing in Differentiated Oxygen
|
N/A | |
Recruiting |
NCT04447872 -
The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming Protocol
|
N/A | |
Completed |
NCT04425317 -
Detection of SARS-CoV-2 in Follicular Fluid and Cumulus-oocyte-complexes in COVID-19 Patients
|
N/A | |
Not yet recruiting |
NCT05932082 -
The Impact of Myomectomy on IVF Outcomes
|
N/A | |
Not yet recruiting |
NCT04283435 -
Endometrial Effects of Sildenafil in Frozen-Thawed Cycles in Women With Thin Endometrium
|
Phase 1 | |
Recruiting |
NCT04654741 -
The Rate of Embryo Euploidy in Progestin-primed Ovarian Stimulation Cycles
|
Phase 4 | |
Completed |
NCT04099784 -
Health of Frozen Transferred Versus Fresh Transferred Children
|
||
Recruiting |
NCT05788822 -
MVA to Improve the Pregnancy Outcome in Aged Infertility Women With Assisted Reproductive Technology
|
N/A | |
Completed |
NCT04956848 -
Comparing KIDScoreā¢ D5 and iDAScore®. The KiDA Study
|
N/A | |
Not yet recruiting |
NCT06048666 -
Platelet Rich Plasma on Ovarian Reserve Parameters and Intra Cytoplasmic Sperm Injection Outcomes in Patients With Diminished Ovarian Reserve
|
Phase 3 | |
Not yet recruiting |
NCT05954962 -
Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.
|
Phase 4 | |
Not yet recruiting |
NCT02698488 -
Embryo Selection by Metabolomic Profiling of Embryo Culture Medium With Mass Spectroscopy as an Adjunct to Morphology
|
N/A | |
Completed |
NCT01385618 -
Gene-polymorphisms Relating to Human Subfertility
|
N/A |