Clinical trial

Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI on the Expression of FSH- and LH-receptors in Granulosa Cells

Name

2107-ABU-010-BL

Description

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.

Trial arms

Trial start

2023-07-05

Estimated PCD

2023-12-30

Trial end

2024-01-30

Status

Recruiting

Phase

Early phase I

Treatment

Follitropin beta injection 150 IU

Participants commence ovarian stimulation on day 2 or 3 of their menstrual cycle with a daily dosage of 150 IU rec-FSH. The dosage will remain constant throughout the course of the stimulation. From the morning of the 5th stimulation day, GnRH-antagonist will be administered daily to prevent LH-rise. As soon as ≥ 3 follicle of a size of 17mm are seen, 0.3 mg GnRH-Agonist will be administered for final oocyte maturation. During ovarian stimulation, follicle puncture procedures with the aspiration of follicular fluid will be performed at the following time: * one follicle on the morning of day 5, before the administration of the first GnRH-antagonist * 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 * two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation. Oocyte retrieval of all other follicles will be carried out 36 hours after injection of the medication for final oocyte maturation.

Arms:

Daily 150 IU recFSH

Other names:

FOLLISTIM AQ

Follitropin beta injection 300 IU

Participants commence ovarian stimulation on day 2 or 3 of their menstrual cycle with a daily dosage of 300 IU rec-FSH. The dosage will remain constant throughout the course of the stimulation. From the morning of the 5th stimulation day, GnRH-antagonist will be administered daily to prevent LH-rise. As soon as ≥ 3 follicle of a size of 17mm are seen, 0.3 mg GnRH-Agonist will be administered for final oocyte maturation. During ovarian stimulation, follicle puncture procedures with the aspiration of follicular fluid will be performed at the following time: * one follicle on the morning of day 5, before the administration of the first GnRH-antagonist * 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 * two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation. Oocyte retrieval of all other follicles will be carried out 36 hours after injection of the medication for final oocyte maturation.

Arms:

Daily 300 IU recFSH

Other names:

FOLLISTIM AQ

Size

Primary endpoint

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

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

Updated at

2023-07-11

1 organization

1 product

4 indications

Organization

ART Fertility Clinics

Product

Follitropin beta

Indication

Ovarian insufficiency

Indication

Infertility

Indication

Female infertility

Indication

infertility