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Sponsored by: |
Instituto Valenciano de Infertilidad, Spain |
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Information provided by: | Instituto Valenciano de Infertilidad, Spain |
ClinicalTrials.gov Identifier: | NCT00802295 |
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 |
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Aneuploidy |
Drug: Gonadotrophins Drug: Low dosis Gonadotrophin |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Single Blind (Subject), Uncontrolled, Crossover Assignment |
Official Title: | Influence of Ovarian Stimulation and Embryo Aneuploidy |
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 |
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standard dosis protocol: Active Comparator
Administration of standard dosis of gonadotrophins for ovarian stimulation.
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Drug: Gonadotrophins
Administration of standard ovarian stimulation protocol
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2: Experimental
Administration of low dosis of Gonadotrophins for ovarian stimulation
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Drug: Low dosis Gonadotrophin |
Ages Eligible for Study: | 18 Years to 29 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jose Remohi, MD PhD | 3496 3050900 | joseremohi@ivi.es |
Contact: Carmen Rubio, PhD | 34963050900 | c.rubio@ivi.es |
Spain | |
Instituto Valenciano de Infertilidad | |
Valencia, Spain, 46015 |
Principal Investigator: | Jose Remohi, MD PhD | IVI Valencia |
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 |
Ovarian hyperstimulation Embryo Aneuploidy Ovarian hyperstimulation and Embryo Aneuploidy Rates |
Aneuploidy Chromosome Aberrations |
Pathologic Processes Aneuploidy Chromosome Aberrations |