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Biosimilar Versus Urinary Gonadotropins (BEMDON)

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Biosimilar recombinant FSH
Urinary FSH
Sponsored by
IVI Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Biosimilar, ovarian stimulation, oocyte donor

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • IVI Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Biosimilar recombinant FSH

Urinary FSH

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of metaphase II oocytes

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2015
Last Updated
July 17, 2015
Sponsor
IVI Madrid
Collaborators
IVI Bilbao
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1. Study Identification

Unique Protocol Identification Number
NCT02503605
Brief Title
Biosimilar Versus Urinary Gonadotropins
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IVI Madrid
Collaborators
IVI Bilbao

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Biosimilar, ovarian stimulation, oocyte donor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biosimilar recombinant FSH
Arm Type
Active Comparator
Arm Description
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
Arm Title
Urinary FSH
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Biosimilar recombinant FSH
Other Intervention Name(s)
Bemfola
Intervention Description
Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH
Intervention Type
Drug
Intervention Name(s)
Urinary FSH
Other Intervention Name(s)
Fostipur
Intervention Description
Controlled ovarian stimulation with 150 IU/day urinary FSH
Primary Outcome Measure Information:
Title
Number of metaphase II oocytes
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Days of treatment
Time Frame
2 weeks
Title
Total dose of gonadotropins (IU)
Time Frame
2 weeks
Title
Estradiol concentration the day of human chorionic gonadotropin (hCG) administration (picograms/mililiterl)
Time Frame
1 day
Title
Progesterone concentration the day of hCG administration (nanograms/mililiter)
Time Frame
1 day
Title
Fertilization rate
Time Frame
1 day
Title
Percentage of cryopreserved embryos
Time Frame
2 weeks
Title
Implantation rate
Time Frame
2 weeks
Title
Cancellation rate
Time Frame
1 week
Title
Degree of satisfaction (numbers 0-10)
Time Frame
1 month
Title
Apoptosis rate in granulosa cells
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Requena, MD, PhD
Phone
+31911802900
Ext
24153
Email
Antonio.Requena@ivi.es
First Name & Middle Initial & Last Name or Official Title & Degree
María Cruz, PhD
Phone
+34911802900
Ext
24155
Email
Maria.Cruz@ivi.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Requena, Md, PhD
Organizational Affiliation
IVI Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVI Madrid
City
Madrid
ZIP/Postal Code
28023
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25735918
Citation
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.
Results Reference
background
PubMed Identifier
25633239
Citation
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.
Results Reference
background

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Biosimilar Versus Urinary Gonadotropins

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