Biomarkers of Endometrial Receptivity

Launched by THE INSTITUTE OF MOLECULAR AND TRANSLATIONAL MEDICINE, CZECH REPUBLIC · Nov 5, 2020

Keywords

ClinConnect Summary

This clinical trial is studying proteins found in cervical mucus to identify new markers that could indicate how ready the uterus is to support a pregnancy. The researchers will compare samples from women who become pregnant after embryo transfer with those who do not, aiming to improve understanding and treatment of infertility during in vitro fertilization (IVF).

To participate, women must be under 37 years old, non-smokers, and have regular menstrual cycles. They should have been trying to conceive for less than five years and have had no more than three unsuccessful fertility treatments. Participants will undergo routine fertility treatments, and all will provide informed consent to join the study. This research could help enhance fertility treatments and improve the chances of pregnancy for women facing infertility challenges.

Gender

FEMALE

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)