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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01164943
First Posted: July 19, 2010
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Juan A Garcia-Velasco, IVI Madrid
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Juan A Garcia-Velasco, 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164943


Locations
Spain
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
ClinicalTrials.gov Identifier: NCT01164943     History of Changes
Other Study ID Numbers: MAD-FB-04-2010-01
First Submitted: July 16, 2010
First Posted: July 19, 2010
Last Update Posted: February 25, 2016
Last Verified: April 2015

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