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Follitropin beta · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Daily 150 IU recFSH | ACTIVE_COMPARATOR | Follitropin beta injection 150 IU daily |
| Daily 300 IU recFSH | ACTIVE_COMPARATOR | Follitropin beta injection 300 IU daily |
| Name | Type | Description |
|---|---|---|
| Follitropin beta injection 150 IU | DRUG | 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. |
| Follitropin beta injection 300 IU | DRUG | 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. |
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) ...
Follitropin beta is being studied for use in ovarian function insufficiency and female infertility, including fertility issues. It is an investigational small molecule in Phase 1 clinical development, evaluated in the context of ovarian stimulation for IVF/ICSI procedures.
Follitropin beta is being developed by Organon & Co., a company traded under the ticker OGN. The drug is currently in Phase 1 clinical development for ovarian function insufficiency and related fertility conditions.
Follitropin beta is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 1 trial has been completed, involving 6 participants, with no active trials currently ongoing.
Follitropin beta has one completed clinical trial, NCT05330130, titled 'Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI in Granulosa Cells.' This Phase 1 study enrolled 6 female participants in the United Arab Emirates and was active-controlled, though not randomized or double-blinded.
Follitropin beta is a small molecule being studied for its role in ovarian stimulation. The completed trial investigated the impact of FSH dosage on granulosa cells during IVF/ICSI, suggesting it may influence ovarian function, though the specific molecular target has not been disclosed.