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Clinical Trials/NCT00802295
NCT00802295
Completed
Not Applicable

Influence of Ovarian Stimulation and Embryo Aneuploidy

Instituto Valenciano de Infertilidad, IVI VALENCIA1 site in 1 country30 target enrollmentDecember 2008

Overview

Phase
Not Applicable
Intervention
Gonadotrophins
Conditions
Aneuploidy
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Enrollment
30
Locations
1
Primary Endpoint
Aneuploidy rate with two different stimulation protocols.
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
April 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA

Eligibility 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
  • Severe Male Factor

Arms & Interventions

standard dosis protocol

Administration of standard dosis of gonadotrophins for ovarian stimulation.

Intervention: Gonadotrophins

2

Administration of low dosis of Gonadotrophins for ovarian stimulation

Intervention: Low dosis Gonadotrophin

Outcomes

Primary Outcomes

Aneuploidy rate with two different stimulation protocols.

Time Frame: three months

Secondary Outcomes

  • Normal blastocyst rate(three months)

Study Sites (1)

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