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Biosimilar Versus Urinary Gonadotropins (BEMDON)

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ClinicalTrials.gov Identifier: NCT02503605
Recruitment Status : Unknown
Verified July 2015 by Antonio Requena, IVI Madrid.
Recruitment status was:  Not yet recruiting
First Posted : July 21, 2015
Last Update Posted : July 21, 2015
Sponsor:
Collaborator:
IVI Bilbao
Information provided by (Responsible Party):
Antonio Requena, IVI Madrid

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Biosimilar recombinant FSH Drug: Urinary FSH Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Infertility

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 Name: 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 Name: Fostipur




Primary Outcome Measures :
  1. Number of metaphase II oocytes [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Days of treatment [ Time Frame: 2 weeks ]
  2. Total dose of gonadotropins (IU) [ Time Frame: 2 weeks ]
  3. Estradiol concentration the day of human chorionic gonadotropin (hCG) administration (picograms/mililiterl) [ Time Frame: 1 day ]
  4. Progesterone concentration the day of hCG administration (nanograms/mililiter) [ Time Frame: 1 day ]
  5. Fertilization rate [ Time Frame: 1 day ]
  6. Percentage of cryopreserved embryos [ Time Frame: 2 weeks ]
  7. Implantation rate [ Time Frame: 2 weeks ]
  8. Cancellation rate [ Time Frame: 1 week ]
  9. Degree of satisfaction (numbers 0-10) [ Time Frame: 1 month ]
  10. Apoptosis rate in granulosa cells [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503605


Contacts
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Contact: Antonio Requena, MD, PhD +31911802900 ext 24153 Antonio.Requena@ivi.es
Contact: María Cruz, PhD +34911802900 ext 24155 Maria.Cruz@ivi.es

Locations
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Spain
IVI Madrid
Madrid, Spain, 28023
Sponsors and Collaborators
IVI Madrid
IVI Bilbao
Investigators
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Principal Investigator: Antonio Requena, Md, PhD IVI Madrid

Publications:
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Responsible Party: Antonio Requena, MD, PhD, IVI Madrid
ClinicalTrials.gov Identifier: NCT02503605    
Other Study ID Numbers: 1504-MAD-024-AR
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Keywords provided by Antonio Requena, IVI Madrid:
Biosimilar
ovarian stimulation
oocyte donor
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs