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

Phase 1

Completed

• Conditions: Ovarian Function Insufficiency; Fertility Issues; Infertility,Female; Infertility
• Interventions: Drug: Follitropin beta injection 150 IU; Drug: Follitropin beta injection 300 IU

• Registration Number: NCT05330130
• Lead Sponsor: ART Fertility Clinics LLC

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Study Start: 2023-07-05
• Primary Completion: 2024-03-30
• Study Completion: 2024-06-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Daily 150 IU recFSH	Follitropin beta injection 150 IU	Follitropin beta injection 150 IU daily
Daily 300 IU recFSH	Follitropin beta injection 300 IU	Follitropin beta injection 300 IU daily

Primary Outcome Measures

Name	Time	Method
Number of FSHR- and LHR of the GC, obtained from one follicle on the morning of day 5, before the administration of the first GnRH-antagonist, punctured during the ovarian stimulation cycle	5 days
Number of FSHR- and LHR of the GC, obtained from tone follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm, punctured during the ovarian stimulation cycle	1 day
Number of FSHR- and LHR of the GC, obtained from two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation, punctured during the ovarian stimulation cycle	1 day
Number of FSHR- and LHR of the GC, obtained from the follicular fluid of follicles aspirated during OPU	1 day

Secondary Outcome Measures

Name	Time	Method
Level of P4 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist	5 days
Level of FSH hormone in the blood, on the day of OPU	1 day
Level of P4 hormone in the blood, on the day of OPU	1 day
Level of FSH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist	5 days
Level of E2 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist	5 days
Level of LH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist	5 days
Level of E2 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm	1 day
Level of P4 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm	1 day
Level of FSH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm	1 day
Level of LH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm	1 day
Level of P4 hormone in the blood, on the morning of the day of final oocyte maturation	1 day
Level of E2 hormone in the blood, on the morning of the day of final oocyte maturation	1 day
Level of FSH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist	5 days
Level of LH hormone in the blood, on the morning of the day of final oocyte maturation	1 day
Level of E2 hormone in the blood, on the day of OPU	1 day
Level of FSH hormone in the blood, on the morning of the day of final oocyte maturation	1 day
Level of P4 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist	5 days
Level of LH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist	5 days
Level of E2 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm	1 day
Level of LH hormone in the blood, on the day of OPU	1 day
Level of E2 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist	5 days
Level of P4 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm	1 day
Level of FSH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm	1 day
Level of LH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm	1 day
Level of E2 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation	1 day
Level of P4 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation	1 day
Level of FSH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation	1 day
Level of LH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation	1 day
Level of E2 hormone in the follicular fluid of follicles aspirated during OPU	1 day
Level of P4 hormone in the follicular fluid of follicles aspirated during OPU	1 day
Level of FSH hormone in the follicular fluid of follicles aspirated during OPU	1 day
Level of LH hormone in the follicular fluid of follicles aspirated during OPU	1 day

Trial Locations

Locations (1)

ART Fertility Clinics LLC; 🇦🇪 Abu Dhabi, United Arab Emirates