Clinical trial

Assessment of Ovarian Responsiveness Through AMH/AFC and Inhibin B/AFC Ratio

Name
001-2024
Description
Ovarian response to gonadotropin stimulation plays a major role in the success of in vitro fertilization (IVF). Anti-müllerian hormone (AMH), inhibin B, and antral follicle count (AFC) are ovarian reserve markers and also predictors of the ovarian response, as they correlate with the number of oocytes retrieved. Ovarian responsiveness can also be assessed through the Follicular Output Rate (FORT), which evaluates the proportion of follicles that developed during stimulation by the ratio of PFC (preovulatory follicle count) to AFC. FORT highlights that some follicles do not respond to the FSH; therefore, this project proposes an endocrinological approach to this issue by relating AFC to inhibin B and AMH ㅡ hormones produced by granulosa cells, but at different stages of folliculogenesis and with endocrine and paracrine functions, respectively. The inhibin B/AFC and AMH/AFC ratios correlated with FORT and the number of oocytes retrieved may help elucidate the mechanisms involved in follicular responsiveness. A prospective cohort study will be conducted with patients of the Insemine Center for Human Reproduction. Antral follicle count and AMH measurement will be performed before IVF cycle initiation, and inhibin B measurement will be carried out on a blood sample collected on the fifth day of ovarian stimulation. The primary outcomes will be the Follicular Output Rate (FORT) and the number of oocytes retrieved. Secondary outcomes include the number of metaphase II oocytes, oocyte quality, fertilization rate and embryo quality.
Trial arms
Trial start
2024-03-01
Estimated PCD
2024-03-20
Trial end
2025-12-31
Status
Not yet recruiting
Treatment
FSH-R
controlled ovarian stimulation for IVF
Size
144
Primary endpoint
serum Inhibin B levels
Day 1 and Day 5 of controlled ovarian stimulation
serum Anti Mullerian Hormone levels
Day 1 and Day 5 of controlled ovarian stimulation
Eligibility criteria
Inclusion Criteria: * first IVF; * without severe male factor involved. Exclusion Criteria: * Patients with endometrioma; * ovarian cyst; * AMH \< 0.5 ng/ml; * increased serum TSH (thyroid-stimulating hormone) or prolactin levels; * endocrinopathies; * previous oophorectomy; * failure to visualize one of the ovaries on ultrasound.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '14 Days', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 144, 'type': 'ESTIMATED'}}
Updated at
2024-03-05

1 organization

1 product

4 indications

Product
FSH-R
Indication
infertility
Indication
Woman