| NCT ID | NCT04619524 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Institute of Molecular and Translational Medicine, Czech Republic |
| Condition | IVF |
| Study Type | INTERVENTIONAL |
| Enrollment | 476 participants |
| Start Date | 2018-05-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 476 participants in total. It began in 2018-05-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Marian Hajduch, MD.PhD.
STUDY DIRECTOR
Palacky University in Olomouc, Faculty of Medicine and Dentristry
Frequently Asked Questions
Who can join the NCT04619524 clinical trial?
This trial is open to female participants only, up to 36 Years, studying IVF. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04619524 currently recruiting?
Yes, NCT04619524 is actively recruiting participants. Contact the research team at radovan.pilka@fnol.cz for enrollment information.
Where is the NCT04619524 trial being conducted?
This trial is being conducted at Brno, Czechia, Olomouc, Czechia, Olomouc, Czechia.
Who is sponsoring the NCT04619524 clinical trial?
NCT04619524 is sponsored by The Institute of Molecular and Translational Medicine, Czech Republic. The principal investigator is Marian Hajduch, MD.PhD. at Palacky University in Olomouc, Faculty of Medicine and Dentristry. The trial plans to enroll 476 participants.