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Biosimilar Versus Urinary Gonadotropins

NCT02503605 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2015-07-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Biosimilar recombinant FSH

Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH

DRUG

Urinary FSH

Controlled ovarian stimulation with 150 IU/day urinary FSH

Sponsors & Collaborators

  • IVI Bilbao

    collaborator OTHER

  • IVI Madrid

    lead OTHER

Principal Investigators

  • Antonio Requena, Md, PhD · IVI Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-03-31
Completion
2016-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02503605 on ClinicalTrials.gov