Biosimilar Versus Urinary Gonadotropins

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Biosimilar recombinant FSH

Intervention Type DRUG

Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH

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

Group Type ACTIVE_COMPARATOR

Urinary FSH

Intervention Type DRUG

Controlled ovarian stimulation with 150 IU/day urinary FSH

Interventions

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Biosimilar recombinant FSH

Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH

Intervention Type DRUG

Urinary FSH

Controlled ovarian stimulation with 150 IU/day urinary FSH

Intervention Type DRUG

Other Intervention Names

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Bemfola Fostipur

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes