RecruitingNot ApplicableNCT04619524
Biomarkers of Endometrial Receptivity
Biomarkers of Endometrial Receptivity: A Prospective Multicenter Study on Proteomic Biomarkers of Endometrial Receptivity in Cervical Mucus ( PRO BIOMER - CM )
Sponsor
The Institute of Molecular and Translational Medicine, Czech Republic
Enrollment
476 participants
Start Date
May 1, 2018
Study Type
INTERVENTIONAL
Conditions
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: FEMALEMax Age: 36 Years
Inclusion Criteria25
- 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
- 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 Criteria33
- 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)
- 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)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DIAGNOSTIC_TESTCervical mucus will be collected from patients undergoing IVF
Patients undergoing hormonal stimulation for IVF will be sampled for cervical mucus.
DIAGNOSTIC_TESTCervical 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.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04619524
Related Trials
Effect of Pentoxyfilline on Endometrial Thickness and Frozen Embryo Transfer Outcomes
NCT074998171 location
Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes
NCT074998041 location
Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients
NCT062393761 location
Aromatherapy for Mental Health Promotion in IVF Patients
NCT074806681 location
Transfer Direct System as a New Method for Embryo Transfer
NCT067440494 locations