NCT04854707

An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data

An Observational Study "FOLLITROPIN" Comparing the Efficacy of Follitropin Alpha Biosimilar: the Real-world Data

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,484 (actual)
• Sponsor: IVFarma LLC · Industry
• Sex: Female
• Age: 20 Years – 43 Years
• Healthy volunteers: Not accepted

Summary

Aim to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.

Detailed description

A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.

Conditions

• Reproductive Issues
• Reproductive Disorder
• Fertility Disorders
• Fertility Issues
• Gynecologic Disease
• IVF

Interventions

Type	Name	Description
DRUG	Follitropin Alfa	Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH.
DRUG	Follicle Stimulating Hormone/Luteinizing Hormone	Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH.
DRUG	Follitropin Alfa	Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression.
DRUG	Follitropin Alfa	Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression.
DRUG	Follicle Stimulating Hormone/Luteinizing Hormone	Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH).

Timeline

• Start date: 2020-01-12
• Primary completion: 2020-12-20
• Completion: 2021-01-20
• First posted: 2021-04-22
• Last updated: 2021-10-22
• Results posted: 2021-10-22

Locations

35 sites across 1 country: Russia