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Also known as Follitropin beta injection, recFSH, Puregon®, Follistim®, recFSH (follitropin beta)
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 ovarian function insufficiency, a condition in which the ovaries do not function normally. The single registered trial also enrolled participants with fertility issues and female infertility in the context of ovarian stimulation for IVF or ICSI. It is an investigational product and has not been approved for these uses.
Follitropin beta targets FSHR, the follicle-stimulating hormone receptor, and acts as an agonist at that receptor. By binding and activating FSHR, it is intended to stimulate ovarian follicular activity. This receptor-level activity is the basis for its study in ovarian stimulation settings.
Follitropin beta is being developed by Organon & Co., which trades under the ticker OGN. Organon is the sponsor associated with the clinical program for this asset in ovarian function insufficiency and related fertility indications.
Follitropin beta is in Phase 1 development. Its only registered trial is a completed Phase 1 study, and there are no active trials listed for the program. It is investigational and has not been approved by the FDA for ovarian function insufficiency or any fertility indication.
Follitropin beta has been studied in one registered trial, NCT05330130, titled Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI in Granulosa Cells. That Phase 1 trial is completed, enrolled 6 participants, used an active control, and was conducted in the United Arab Emirates in female participants aged 18 years and older.