Biosimilar Versus Urinary Gonadotropins (BEMDON)

IVI Madrid

Status and phase: Unknown; Phase 4

Conditions: Infertility

Treatments: Drug: Biosimilar recombinant FSH; Drug: Urinary FSH

Study type: Interventional

Funder types: Other

Identifiers

NCT02503605

1504-MAD-024-AR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Biosimilar recombinant FSH

Active Comparator group

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

Treatment:

Drug: Biosimilar recombinant FSH

Urinary FSH

Active Comparator group

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

Treatment:

Drug: Urinary FSH