Embryo Aneuploidies and Ovarian Stimulation

Study Overview
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Brief Summary
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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.

Official Title
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Incidence of EmbyoO Aneuploidies in Natural Versus Stimulated Cycles in the Same Women.

Conditions
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Embryo Aneuploidies

Intervention / Treatment
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* Procedure: Preimplantation Genetic Diagnosis


Participation Criteria
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Eligibility Criteria
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Donor Inclusion Criteria: 18 to 35 years old. BMI: 18-25Kg/m2 Regular menstrual cycles Normal kariotype No previous controlled ovarian hyperstimulation (COH) treatments. Donor Exclusion Criteria: Endometriosis Policystic ovarian syndrome Recurrent miscarriages. Recipient Inclusion Criteria Aged until 45 years old No systemic diseases Following egg and sperm donation treatment. Recipient exclusion criteria: Uterine disease (polyps, myomas, mullerian defects) Recurrent miscarriages.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Natural cycle oocyte donation | |
| Active Comparator: 2<br>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. | Procedure: Preimplantation Genetic Diagnosis<br>* Preimplantation Genetic Diagnosis (PGD) is performed on the embryos resulting from these natural and stimulated cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo aneuploidies |  | 2 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aneuploidies, natural cycle, stimulated cycle, preimplantation genetic diagnosis