Inhibin B/AFC Ratio for Ovarian Response

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292806
• Other study ID #: 001-2024
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• IVF
• Ovulation Disorder

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