Biosimilar Versus Urinary Gonadotropins

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: IVI Madrid
• Collaborator: IVI Bilbao
• Treatments: Follicle Stimulating Hormone; Hormones

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