Trial | NCT02503605  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    follitropin alfa ...

  • Study Participants

    130
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.
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 Started
Oct 31
2015
Primary Completion
Mar 31
2016
Anticipated
Study Completion
Jun 30
2016
Anticipated
Last Update
Jul 21
2015
Estimate

Drug Biosimilar recombinant FSH

Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH

  • Other names: Bemfola

Drug Urinary FSH

Controlled ovarian stimulation with 150 IU/day urinary FSH

  • Other names: Fostipur

Biosimilar recombinant FSH Active Comparator

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

Urinary FSH Active Comparator

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

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
No Results Posted