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

This study has been terminated.
Information provided by (Responsible Party):
Juan A Garcia-Velasco, IVI Madrid Identifier:
First received: July 16, 2010
Last updated: February 24, 2016
Last verified: April 2015
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
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:

Further study details as provided by IVI Madrid:

Primary Outcome Measures:
  • Aneuploidy Rate [ Time Frame: 2011 January ]
    Analysis of all nuclei fixed

Secondary Outcome Measures:
  • Oocyte morphology [ Time Frame: 2011 january ]
    Analysis of all oocytes

  • Outcome rates (implantation, pregnancy and miscarriage rate) [ Time Frame: 2011 April ]
    Time requierd to know all the implantation, pregnancy and miscarriage rate

Enrollment: 80
Study Start Date: July 2010
Study Completion Date: December 2012
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


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Male factor
  • Uterine malformations
  • genetic alterations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01164943

Insituto Valenciano de Infertilida, Spain, Madrid
Madrid, Spain, 28023
Sponsors and Collaborators
IVI Madrid
  More Information

Responsible Party: Juan A Garcia-Velasco, PhD, MD, IVI Madrid Identifier: NCT01164943     History of Changes
Other Study ID Numbers: MAD-FB-04-2010-01
Study First Received: July 16, 2010
Last Updated: February 24, 2016

Additional relevant MeSH terms:
Chromosome Aberrations
Pathologic Processes
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on March 29, 2017