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Aneuploidies and Different Stimulation Protocols
This study is not yet open for participant recruitment.
Verified by Instituto Valenciano de Infertilidad, Spain, December 2008
First Received: December 3, 2008   Last Updated: December 4, 2008   History of Changes
Sponsored by: Instituto Valenciano de Infertilidad, Spain
Information provided by: Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT00802295
  Purpose

Our working hypothesis is that patients undergoing "in vitro" fertilization (IVF) with higher response to ovarian stimulation protocols recover a higher number of oocytes and, this elevated response could be translated into increased incidence of chromosomally abnormal embryos. Our objective is to develop a prospective study on healthy young donors, with a previous cycle with high ovarian response (>20 oocytes and/or E2 levels the day of the hCG injection >3000 pg/mL), but without developing mild or severe hyperstimulation syndrome. After signing a proper written consent, these donors would agree to undergo two subsequent stimulation cycles following two different protocols. In one cycle the stimulation pattern would be similar to the previous one, with elevated response and, in another cycle the amount of gonadotropins would be cut down in order to obtain lower ovarian response.

Oocytes obtained in each cycle would be donated to anonymous recipients and after fertilization, embryo quality and chromosomal status of the resulting embryos would be evaluated. Preimplantation genetic diagnosis (PGD) will be performed on day-3 embryos and chromosomes 13, 15, 16, 17, 18, 21, 22, X and Y would be analyzed by fluorescence "in situ" hybridization (FISH).


Condition Intervention
Aneuploidy
Drug: Gonadotrophins
Drug: Low dosis Gonadotrophin

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Single Blind (Subject), Uncontrolled, Crossover Assignment
Official Title: Influence of Ovarian Stimulation and Embryo Aneuploidy

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

Primary Outcome Measures:
  • Aneuploidy rate with two different stimulation protocols. [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Normal blastocyst rate [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
standard dosis protocol: Active Comparator
Administration of standard dosis of gonadotrophins for ovarian stimulation.
Drug: Gonadotrophins
Administration of standard ovarian stimulation protocol
2: Experimental
Administration of low dosis of Gonadotrophins for ovarian stimulation
Drug: Low dosis Gonadotrophin

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women between 18 - 29
  • with previous cycle with standard dosis of Gonadotrophin and high response to the treatment (> 20 oocytes)
  • No symptom of OHSS

Exclusion Criteria:

  • donors with 2 previous miscarriages
  • PCO
  • Severe Male Factor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802295

Contacts
Contact: Jose Remohi, MD PhD 3496 3050900 joseremohi@ivi.es
Contact: Carmen Rubio, PhD 34963050900 c.rubio@ivi.es

Locations
Spain
Instituto Valenciano de Infertilidad
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Principal Investigator: Jose Remohi, MD PhD IVI Valencia
  More Information

No publications provided

Responsible Party: IVI Valencia ( Jose Remohi Jimenez )
Study ID Numbers: VLC-JR-0204-307-11
Study First Received: December 3, 2008
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00802295     History of Changes
Health Authority: Spain: Ministry of Health

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
Ovarian
hyperstimulation
Embryo
Aneuploidy
Ovarian hyperstimulation and Embryo Aneuploidy Rates

Study placed in the following topic categories:
Aneuploidy
Chromosome Aberrations

Additional relevant MeSH terms:
Pathologic Processes
Aneuploidy
Chromosome Aberrations

ClinicalTrials.gov processed this record on May 07, 2009