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FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)

NCT01969201 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 710

Last updated 2019-10-09

Study results available
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Summary

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.

Conditions

Interventions

DRUG

Urofollitrophin

DRUG

Follitrophin alpha

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Principal Investigators

  • Pedro Barri, MD · Institut Universitari Dexeus, Barcelona, Spain

  • Christophe Blockeel, MD · Universitair Ziekenhuis Brussel, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-06-30
Completion
2017-08-31

Countries

  • Belgium
  • Italy
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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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 NCT01969201 on ClinicalTrials.gov