Study Results
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Basic Information
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COMPLETED
PHASE4
INTERVENTIONAL
2008-02-29
2010-02-28
Brief Summary
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The main question remaining is if COH may increase the aneuploidies rate in young and healthy women. Therefore, the primary endpoint of the present study is to analyse the incidence of chromosomal abnormalities in this group of patients (oocyte donors), either in oocytes obtained after a natural cycle or in those retrieved after a COH cycle. To get rid of the male factor influence, donated sperm will be used.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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1
Natural cycle oocyte donation
No interventions assigned to this group
2
Stimulated cycle oocyte donation.
* Long protocol down-regulation with a GnRH agonist, starting on the midluteal phase of the previous cycle with leuprolide acetate (0.2mg/day).
* Once evidence of downregulation is documented, leuprolide will be halved to 0.1 mg daily.
* COH with be carried on with gonadotropins (150UI/day of rFSH and 75 UI/day of HP-hMG). The dose can be adjusted according to ovarian response as judged by ultrasound and by serum oestradiol (E 2 ) concentrations.
Preimplantation Genetic Diagnosis
Preimplantation Genetic Diagnosis (PGD) is performed on the embryos resulting from these natural and stimulated cycles.
Interventions
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Preimplantation Genetic Diagnosis
Preimplantation Genetic Diagnosis (PGD) is performed on the embryos resulting from these natural and stimulated cycles.
Eligibility Criteria
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Inclusion Criteria
* BMI: 18-25Kg/m2
* Regular menstrual cycles
* Normal kariotype
* No previous controlled ovarian hyperstimulation (COH) treatments.
* Aged until 45 years old
* No systemic diseases
* Following egg and sperm donation treatment.
Exclusion Criteria
* Policystic ovarian syndrome
* Recurrent miscarriages.
* Uterine disease (polyps, myomas, mullerian defects)
* Recurrent miscarriages.
18 Years
35 Years
FEMALE
Yes
Sponsors
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Instituto Valenciano de Infertilidad, IVI VALENCIA
OTHER
Responsible Party
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Instituto Valenciano de Infertilidad, Spain
Locations
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Instituto Valenciano de Infertilidad
Valencia, Valencia, Spain
Countries
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References
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Labarta E, Bosch E, Alama P, Rubio C, Rodrigo L, Pellicer A. Moderate ovarian stimulation does not increase the incidence of human embryo chromosomal abnormalities in in vitro fertilization cycles. J Clin Endocrinol Metab. 2012 Oct;97(10):E1987-94. doi: 10.1210/jc.2012-1738. Epub 2012 Aug 3.
Other Identifiers
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0607-C-M09-EL
Identifier Type: -
Identifier Source: org_study_id
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