Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI in Granulosa Cells

ART Fertility Clinics LLC

Status and phase: Completed; Phase 1

Conditions: Ovarian Function Insufficiency; Infertility; Infertility,Female; Fertility Issues

Treatments: Drug: Follitropin beta injection 300 IU; Drug: Follitropin beta injection 150 IU

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05330130

2107-ABU-010-BL

Details and patient eligibility

About

To study the influence of different daily rec-FSH dosages (150 IU versus 300 IU), performed in the same patient in consecutive cycles, on the relation between FSH- and LH-receptors of the granulosa cells of the growing follicle.

Full description

This is a prospective cross-over study. Investigators want to study the effect of different dosages of recombinant FSH in the same patient on the expression of the FSH- and LH-receptors in the granulosa cells and on the endocrine milieu in the blood and the follicular fluid. An improved understanding of the mechanism leading to progesterone elevation might initiate a change in the ovarian stimulation approach, thereby not only preventing progesterone elevation and its negative consequences on ART (Assisted Reproductive Technology) outcome, but also improving individualization of the ovarian stimulation treatment according to the patients' characteristics.

Enrollment: 6 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Desire to perform oocyte freezing for social fertility preservation, age 18 - 38 years
• BMI of 18-32 kg/m2
• Regular menstrual cycles with a length of 24-35 days
• Anti-Muellerian-Hormone levels between 1.3 - 6.25 ng/ml (Ferraretti and Gianaroli, 2014; Calzada et al., 2019)

Exclusion criteria

• Occurrence of ovarian hyperstimulation syndrome (OHSS)
• Occurrence of poor ovarian response (AFC < 5 and AMH < 0,5ng/ml) in previous ovarian stimulation treatment (20)
• Polycystic ovary syndrome (PCOS) (21)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Daily 150 IU recFSH

Active Comparator group

Description:

Follitropin beta injection 150 IU daily

Treatment:

Drug: Follitropin beta injection 150 IU

Daily 300 IU recFSH

Active Comparator group

Description:

Follitropin beta injection 300 IU daily

Treatment:

Drug: Follitropin beta injection 300 IU