Actively Recruiting
Biomarkers of Endometrial Receptivity: A Prospective Multicenter Study on Proteomic Biomarkers of Endometrial Receptivity in Cervical Mucus ( PRO BIOMER - CM )
Led by The Institute of Molecular and Translational Medicine, Czech Republic · Updated on 2026-03-20
476
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Institute of Molecular and Translational Medicine, Czech Republic
Lead Sponsor
U
University Hospital Olomouc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating proteins in cervical mucus to find new biomarkers that could indicate when the lining of the uterus (endometrium) is receptive to embryo implantation. This study focuses on women undergoing infertility treatments such as fresh or frozen embryo transfers. The goal is to improve the understanding of endometrial receptivity, which is crucial for successful implantation but is currently difficult to assess due to a lack of reliable markers. Participants are divided into two groups: those undergoing cycles with fresh embryo transfers and those with frozen embryo transfers. Cervical mucus samples will be collected during these treatment cycles and analyzed using a highly sensitive mass spectrometer to detect protein patterns. The study aims to compare protein profiles between patients who become pregnant and those who do not, seeking new biomarkers to guide clinical decisions. During the study, participants will have cervical mucus collected as part of their infertility treatment cycles. Researchers will analyze these samples over a period of 48 months to identify protein differences related to pregnancy outcomes. The study will monitor and compare protein spectra to detect new markers of endometrial receptivity. This research could help improve timing and success rates of embryo transfers in the future.
CONDITIONS
Brief Title
Biomarkers of Endometrial Receptivity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged less than 37 years (up to 36 years and 364 days)
- Non-smoker
- Normal menstrual cycles lasting between 25 to 35 days
- Infertility duration less than five years
- Normal responder to fertility treatment
- Fewer than three failed assisted reproduction cycles including fresh or frozen embryo transfers
- Sperm obtained through ejaculation with spermiogram more than 5 million sperm/mL
- Body mass index (BMI) between 19 and 29 kg/m2
- Follicle stimulating hormone (FSH) less than 10 IU/L on the third day of cycle
- Basal antral follicle count between 5 and 15 (for stimulated cycle)
- Undergoing routine gonadotrophin-releasing hormone agonist or antagonist protocols (for stimulated cycle)
- Undergoing routine estrogen/progesterone substituted cycle (for substituted cycle)
- Provided informed consent
You will not qualify if you...
- Genetic disease
- Metabolic and/or endocrine disorders including diabetes, metabolic syndrome, thyroid disorders
- Polycystic ovary syndrome as defined by Rotterdam criteria
- Prior diagnosis of endometriosis or adenomyosis
- Previous gynecological or pelvic surgery except for salpingectomy
- Repeated spontaneous abortions (two or more)
- Previous ovarian hyperstimulation syndrome (OHSS)
- Less than 5 or more than 20 retrieved oocytes in previous cycles
- Serum anti-Mullerian hormone value less than 1.0 mIU/ml (stimulated cycle) or less than 0.5 mIU/ml (substituted cycle)
- Presence of any structural abnormality of the reproductive system
- Donor oocyte cycles
- Severe male factor infertility (less than 5 million sperm/mL)
- Low response to stimulation
- Endometrium thickness less than 8 mm at day of hCG or embryo transfer
- Low fertilization capacity (fertilization rate less than 20% or late ICSI after IVF failure)
- IVF cycle cancelled before embryo transfer
- Transfer of other than one high-quality blastocyst (at least grade 3BB)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the IVF or cryopreserved embryo transfer cycle
Participants undergo cervical mucus collection during their IVF or cryopreserved embryo transfer cycles to analyze proteins related to endometrial receptivity.
1 to 2 visits depending on treatment cycle
Duration - Up to 48 months
Participants are monitored for pregnancy outcomes and biomarker analysis results over the study period.
Periodic follow-up visits as scheduled
Trial Site Locations
Total: 3 locations
1
Brno University Hospital
Brno, South Moravian, Czechia, 62500
Actively Recruiting
2
University Hospital Olomouc
Olomouc, Czechia, 77900
Actively Recruiting
3
University Hospital Olomouc
Olomouc, Czechia
Actively Recruiting
Research Team
R
Radovan Pilka, Prof.MD.PhD.
P
Petr Dzubak, MD.PhD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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