Biosimilar Versus Urinary Gonadotropins

Infertility Clinical Trial

— BEMDON  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02503605
• Other study ID #: 1504-MAD-024-AR
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 16, 2015
• Last updated: July 17, 2015
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2015
• Source: IVI Madrid
• Contact: Antonio Requena, MD, PhD
• Phone: +31911802900
• Email: Antonio.Requena[@]ivi.es
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Patients aged 18-35 years who meet the criteria for entry into the oocyte donor program and that are going to undergo controlled ovarian stimulation

Exclusion Criteria:

• Patient with a basal antral count> 20 follicles in total or <6 antral follicles per ovary

• Patients with comorbidities that, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation

• The presence of ovarian cysts that judgment of the investigator would interfere with the stimulation or may pose a risk to the donor

• BMI <18 kg / m2

• BMI> 30 kg / m2

• Severe hypersensitivity to drugs with similar structure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Biosimilar recombinant FSH
Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH
• Urinary FSH
Controlled ovarian stimulation with 150 IU/day urinary FSH

Locations

Country	Name	City	State
Spain	IVI Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
IVI Madrid	IVI Bilbao

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Rettenbacher M, Andersen AN, Garcia-Velasco JA, Sator M, Barri P, Lindenberg S, van der Ven K, Khalaf Y, Bentin-Ley U, Obruca A, Tews G, Schenk M, Strowitzki T, Narvekar N, Sator K, Imthurn B. A multi-centre phase 3 study comparing efficacy and safety of Bemfola(®) versus Gonal-f(®) in women undergoing ovarian stimulation for IVF. Reprod Biomed Online. 2015 May;30(5):504-13. doi: 10.1016/j.rbmo.2015.01.005. Epub 2015 Jan 27. — View Citation

Wolzt M, Gouya G, Sator M, Hemetsberger T, Irps C, Rettenbacher M, Vcelar B. Comparison of pharmacokinetic and safety profiles between Bemfola(®) and Gonal-f (®) after subcutaneous application. Eur J Drug Metab Pharmacokinet. 2015 Jan 30. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of metaphase II oocytes		1 day	No
Secondary	Days of treatment		2 weeks	No
Secondary	Total dose of gonadotropins (IU)		2 weeks	No
Secondary	Estradiol concentration the day of human chorionic gonadotropin (hCG) administration (picograms/mililiterl)		1 day	No
Secondary	Progesterone concentration the day of hCG administration (nanograms/mililiter)		1 day	No
Secondary	Fertilization rate		1 day	No
Secondary	Percentage of cryopreserved embryos		2 weeks	No
Secondary	Implantation rate		2 weeks	No
Secondary	Cancellation rate		1 week	No
Secondary	Degree of satisfaction (numbers 0-10)		1 month	No
Secondary	Apoptosis rate in granulosa cells		1 month	No