Biomarkers of Endometrial Receptivity
BIOMER
1 other identifier
interventional
476
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 20, 2026
March 1, 2026
8.7 years
November 2, 2020
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Comparison of the protein analysis between the pregnant and not pregnant patients
48 months
Detection of the new endometrial receptivity biomarkers.
48 months
Study Arms (2)
A: Patients undergo cycle with the transfer of fresh embryos
EXPERIMENTALIn 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
EXPERIMENTALIn study group B cervical mucus will be sampled from patients undergoing treatment cycles with the transfer of cryopreserved embryos.
Interventions
Patients undergoing hormonal substitution for transfer of cryopreserved embryos will be sampled for cervical mucus.
Patients undergoing hormonal stimulation for IVF will be sampled for cervical mucus.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Brno University Hospital
Brno, South Moravian, 62500, Czechia
University Hospital Olomouc
Olomouc, 77900, Czechia
University Hospital Olomouc
Olomouc, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marian Hajduch, MD.PhD.
Palacky University in Olomouc, Faculty of Medicine and Dentristry
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2020
First Posted
November 6, 2020
Study Start
May 1, 2018
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 20, 2026
Record last verified: 2026-03