Clinical Trials in Czechia / NCT04619524
Recruiting Not applicable

Biomarkers of Endometrial Receptivity

NCT04619524 · tracked via the Priya Life Science Czechia tracker
Phase
Not applicable
Started
2018-05-01
Last updated
2026-03-20

Condition(s) studied

IVFInfertility TreatmentFertility DisordersEmbryo Transfer

Investigational drug(s) / intervention(s)

Cervical mucus will be collected from patients undergoing IVFCervical mucus will be collected from patients undergoing transfer of cryopreserved embryos

Cervical mucus will be collected from patients undergoing IVF: Patients undergoing hormonal stimulation for IVF will be sampled for cervical mucus.

Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryos: Patients undergoing hormonal substitution for transfer of cryopreserved embryos will be sampled for cervical mucus.

Study 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.

Eligibility

Sex
FEMALE
Min age
—
Max age
36 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Brno University Hospital Brno South Moravian Recruiting
University Hospital Olomouc Olomouc Czechia Recruiting
University Hospital Olomouc Olomouc Czechia Recruiting

More The Institute of Molecular and Translational Medicine, Czech Republic trials in Czechia

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04619524 on ClinicalTrials.gov ↗ ← All trials in Czechia