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New treatment option for IVF
Official title Biomarkers of Endometrial Receptivity
ClinicalTrials.gov ID: NCT04619524
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 36, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Brno, South Moravian, Czechia
- Olomouc, Czechia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, up to 36 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brno, South Moravian, Czechia; Olomouc, Czechia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.