Inhibin B/AFC Ratio for Ovarian Response

Not yet recruiting

• Conditions: Ovulation Disorder; IVF; Infertility, Female

• Registration Number: NCT06292806
• Lead Sponsor: Insemine Humen Reproduction Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-20
• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Last Update Submitted: 2024-03-01
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05
• Primary Completion: 2024-03-20
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 144

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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