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Aneuploidy Rate and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH

This study is currently recruiting participants.
Verified March 2012 by Instituto Valenciano de Infertilidad, Spain
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01164943
First received: July 16, 2010
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  Purpose

Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone on aneuploidy rate it is unknown. If there was an increase on aneuploidy rate of one of these stimulation protocols, there will be a negative effect on the successful rates in the egg donation cycles. The aim of this study is to observe if there is a different in aneuploidy rate and morphological oocyte parameters between different stimulation protocols.


Condition Intervention
Aneuploidy Rate
 Procedure: Stimulation with human FSH
Procedure: Stimulation with recombinant FSH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Aneuploidy Rate Impact in Oocyte From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • Aneuploidy Rate [ Time Frame: 2011 January ] [ Designated as safety issue: Yes ]
    Analysis of all nuclei fixed


Secondary Outcome Measures:
  • Oocyte morphology [ Time Frame: 2011 january ] [ Designated as safety issue: No ]
    Analysis of all oocytes

  • Outcome rates (implantation, pregnancy and miscarriage rate) [ Time Frame: 2011 April ] [ Designated as safety issue: No ]
    Time requierd to know all the implantation, pregnancy and miscarriage rate


Estimated Enrollment: 80
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Human FSH Procedure: Stimulation with human FSH
Human FSH
Active Comparator: Recombinant FSH Procedure: Stimulation with recombinant FSH
Recombinant FSH

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Egg donation cycles with more than 8MII in oocyte retrieval day

Exclusion Criteria:

  • Male factor
  • Uterine malformations
  • genetic alterations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164943

Locations
Spain
Insituto Valenciano de Infertilida, Spain, Madrid Recruiting
Madrid, Spain, 28023
Contact: Fernando F Bronet, PhD     +34911802900 ext 24521     fbronet@ivi.es    
Principal Investigator: Eva E Martinez, PhD            
Principal Investigator: David D Agudo, PhD            
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
  More Information

No publications provided

Responsible Party: Fernando Bronet, PhD, Instituto Valenciano de Infertilidad, Spain, Madrid (IVI- Madrid)
ClinicalTrials.gov Identifier: NCT01164943     History of Changes
Other Study ID Numbers: MAD-FB-04-2010-01
Study First Received: July 16, 2010
Last Updated: March 30, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Follicle Stimulating Hormone
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013