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
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 21, 2015
July 1, 2015
5 months
July 16, 2015
July 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of metaphase II oocytes
1 day
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (2)
Biosimilar recombinant FSH
ACTIVE COMPARATORUnder 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
Urinary FSH
ACTIVE COMPARATORUnder 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
Interventions
Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH
Controlled ovarian stimulation with 150 IU/day urinary FSH
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IVI Madridlead
- IVI Bilbaocollaborator
Study Sites (1)
IVI Madrid
Madrid, Madrid, 28023, Spain
Related 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((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.
PMID: 25735918BACKGROUNDWolzt 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.
PMID: 25633239BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Requena, Md, PhD
IVI Madrid
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
July 16, 2015
First Posted
July 21, 2015
Study Start
October 1, 2015
Primary Completion
March 1, 2016
Study Completion
June 1, 2016
Last Updated
July 21, 2015
Record last verified: 2015-07