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OpenTrials
Completed

NCT Number: NCT00802295

Aneuploidies and Different Stimulation Protocols

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).

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Key information

Age range

18 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Valenciano de Infertilidad

Valencia, 46015, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gonadotrophins

Drug

Administration of standard ovarian stimulation protocol

Low dosis Gonadotrophin

Drug

Primary outcomes

  1. Aneuploidy rate with two different stimulation protocols.

    Time frame: three months

Secondary outcomes

  1. Normal blastocyst rate

    Time frame: three months

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Official study title

Influence of Ovarian Stimulation and Embryo Aneuploidy

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 4, 2008
Registry last updated
Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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