Inhibin B/AFC Ratio for Ovarian Response

NCT ID: NCT06292806

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-12-31

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.

Conditions

IVF; Infertility, Female; Ovulation Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

FSH-R

controlled ovarian stimulation for IVF

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Insemine Humen Reproduction Centre

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

001-2024

Identifier Type: -

Identifier Source: org_study_id