NCT02503605

Biosimilar Versus Urinary Gonadotropins

Prospective Randomized Clinical Trial to Test the Efficacy of a Biosimilar Recombinant Follicle Stimulating Hormone (FSH)vs. Urinary FSH in an Oocyte Donation Program

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: IVI Madrid · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step in simplifying fertility treatments, making them easier to manage and more accessible to patients. Taking in mind these arguments ,the study is proposed for determining equivalence in terms of biological effectiveness of an ovarian stimulation protocol with biosimilar recombinant FSH stimulation protocol vs. urinary FSH in oocyte donation program.

Detailed description

Biosimilar products are drugs "like" biotechnological origin to other innovative biological medicines and that can be marketed once the patent has expired. These drugs are intended to achieve the same therapeutic benefit as biological medicinal resembles. Because of the similarity in both the active substance in the formulation, it is intended to demonstrate the equivalence between the biosimilar medicine of recombinant FSH and FSH of urinary origin in terms of fitness. The investigators' main objective is to perform a non-inferiority trial of biosimilar recombinant FSH product compared to a conventional ovarian stimulation protocol with urinary FSH in relation to the number of oocytes retrieved and the number of metaphase II oocytes.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Biosimilar recombinant FSH	Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH
DRUG	Urinary FSH	Controlled ovarian stimulation with 150 IU/day urinary FSH

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-03-01
• Completion: 2016-06-01
• First posted: 2015-07-21
• Last updated: 2015-07-21

Locations

1 site across 1 country: Spain