Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-06 @ 2:41 AM
Study NCT ID:
NCT02503605
Status:
UNKNOWN
Last Update Posted:
2015-07-21
First Post:
2015-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biosimilar Versus Urinary Gonadotropins
Sponsor:
IVI Madrid
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2015-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEMDON
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: