Biosimilar Versus Urinary Gonadotropins

Study Overview
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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.

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.

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Biosimilar recombinant FSH
* Drug: Urinary FSH


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biosimilar recombinant FSH<br>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<br>* Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH<br>* Other names: Bemfola;|
| Active Comparator: Urinary FSH<br>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<br>* Controlled ovarian stimulation with 150 IU/day urinary FSH<br>* Other names: Fostipur;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of metaphase II oocytes |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biosimilar, ovarian stimulation, oocyte donor