Biosimilar Versus Urinary Gonadotropins (BEMDON)

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

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.

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Drug: Biosimilar recombinant FSH; Drug: Urinary FSH

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Antonio Requena, MD, PhD; Phone Number: 24153 +31911802900; Email: Antonio.Requena@ivi.es
• Study Contact Backup: Name: María Cruz, PhD; Phone Number: 24155 +34911802900; Email: Maria.Cruz@ivi.es

Study Locations

• Spain
  • Madrid, Spain, 28023
    • IVI Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biosimilar recombinant FSH; Under current practice, 65 participants will be stimulated with 150 international units (IU)/day biosimilar recombinant FSH, .Daily doses of 0.25 miligrams gonadotropin-releasing hormone (GnRH) antagonist will start on day 6 of stimulation. From this day may also vary the dose of recombinant FSH biosimilar according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.1 miligram GnRH agonist will be administered for triggering final oocyte maturation	Drug: Biosimilar recombinant FSH; Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH; Other Names: Bemfola
Active Comparator: Urinary FSH; Under current practice, 65 participants will be stimulated with 150 IU/day of urinary FSH. Daily doses of 0.25 miligrams gonadotropin-releasing hormone (GnRH) antagonist will start on day 6 of stimulation From this day may also vary the dose of urinary FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.1 miligram GnRH agonist will be administered for triggering final oocyte maturation	Drug: Urinary FSH; Controlled ovarian stimulation with 150 IU/day urinary FSH; Other Names: Fostipur

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of metaphase II oocytes	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Days of treatment	2 weeks
Total dose of gonadotropins (IU)	2 weeks
Estradiol concentration the day of human chorionic gonadotropin (hCG) administration (picograms/mililiterl)	1 day
Progesterone concentration the day of hCG administration (nanograms/mililiter)	1 day
Fertilization rate	1 day
Percentage of cryopreserved embryos	2 weeks
Implantation rate	2 weeks
Cancellation rate	1 week
Degree of satisfaction (numbers 0-10)	1 month
Apoptosis rate in granulosa cells	1 month

Collaborators and Investigators

• Sponsor: IVI Madrid
• Collaborators: IVI Bilbao
• Investigators: Principal Investigator: Antonio Requena, Md, PhD, IVI Madrid

Publications and helpful links

General Publications

• 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((R)) versus Gonal-f((R)) 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.
• Wolzt M, Gouya G, Sator M, Hemetsberger T, Irps C, Rettenbacher M, Vcelar B. Comparison of pharmacokinetic and safety profiles between Bemfola((R)) and Gonal-f((R)) after subcutaneous application. Eur J Drug Metab Pharmacokinet. 2016 Jun;41(3):259-65. doi: 10.1007/s13318-015-0257-6. Epub 2015 Jan 30.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: July 17, 2015
• First Posted (Estimate): July 21, 2015

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 17, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Biosimilar; ovarian stimulation; oocyte donor
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 1504-MAD-024-AR