Aneuploidies and Different Stimulation Protocols

Brief Title

Aneuploidies and Different Stimulation Protocols

Official Title

Influence of Ovarian Stimulation and Embryo Aneuploidy

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).
    



Study Type

Interventional


Primary Outcome

Aneuploidy rate with two different stimulation protocols.

Secondary Outcome

 Normal blastocyst rate

Condition

Aneuploidy

Intervention

Gonadotrophins

Study Arms / Comparison Groups

 standard dosis protocol
Description:  Administration of standard dosis of gonadotrophins for ovarian stimulation.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

December 2008

Completion Date

April 2009

Primary Completion Date

April 2009

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

          -  PCO

          -  Severe Male Factor
      

Gender

Female

Ages

18 Years - 29 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jose Remohi, MD PhD, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT00802295

Organization ID

VLC-JR-0204-307-11



Study Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA


Study Sponsor

Jose Remohi, MD PhD, Principal Investigator, IVI Valencia


Verification Date

September 2009