Embryo Aneuploidies and Ovarian Stimulation
Incidence of EmbyoO Aneuploidies in Natural Versus Stimulated Cycles in the Same Women.
1 other identifier
interventional
N/A
1 country
1
Brief Summary
There is a considerable concern about the effects of controlled ovarian hyperstimulation (COH) for In Vitro Fertilization- Embryo Transfer (IVF-ET) on embryo quality and on the incidence of chromosomal abnormalities in oocytes and embryos. 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.
Trial Health
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Started Feb 2008
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 30, 2008
CompletedFirst Posted
Study publicly available on registry
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMarch 26, 2010
March 1, 2010
2 years
June 30, 2008
March 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Embryo aneuploidies
2 cycles
Study Arms (2)
1
NO INTERVENTIONNatural cycle oocyte donation
2
ACTIVE COMPARATORStimulated 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.
Interventions
Preimplantation Genetic Diagnosis (PGD) is performed on the embryos resulting from these natural and stimulated cycles.
Eligibility Criteria
You may qualify if:
- to 35 years old.
- BMI: 18-25Kg/m2
- Regular menstrual cycles
- Normal kariotype
- No previous controlled ovarian hyperstimulation (COH) treatments.
You may not qualify if:
- Endometriosis
- Policystic ovarian syndrome
- Recurrent miscarriages.
- Aged until 45 years old
- No systemic diseases
- Following egg and sperm donation treatment.
- Uterine disease (polyps, myomas, mullerian defects)
- Recurrent miscarriages.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Valenciano de Infertilidad
Valencia, Valencia, 46015, Spain
Related Publications (1)
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.
PMID: 22865900DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 30, 2008
First Posted
July 1, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
March 26, 2010
Record last verified: 2010-03