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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06292806
Other study ID # 001-2024
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source Insemine Humen Reproduction Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 144
Est. completion date December 31, 2025
Est. primary completion date March 20, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
FSH-R
controlled ovarian stimulation for IVF

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Insemine Humen Reproduction Centre

Outcome

Type Measure Description Time frame Safety issue
Primary serum Inhibin B levels Day 1 and Day 5 of controlled ovarian stimulation
Primary serum Anti Mullerian Hormone levels Day 1 and Day 5 of controlled ovarian stimulation
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