BEMDON: Biosimilar Versus Urinary Gonadotropins
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Number of metaphase II oocytes [1 day]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
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Severe hypersensitivity to drugs with similar structure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IVI Madrid | Madrid | Spain | 28023 |
Sponsors and Collaborators
- IVI Madrid
- IVI Bilbao
Investigators
- Principal Investigator: Antonio Requena, Md, PhD, IVI Madrid
Study Documents (Full-Text)
None provided.More Information
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(®) 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.
- 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. 2016 Jun;41(3):259-65. doi: 10.1007/s13318-015-0257-6. Epub 2015 Jan 30.
- 1504-MAD-024-AR