Aneuploidies and Different Stimulation Protocols

Study Overview
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Brief Summary
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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).

Official Title
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Influence of Ovarian Stimulation and Embryo Aneuploidy

Conditions
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Aneuploidy

Intervention / Treatment
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* Drug: Gonadotrophins
* Drug: Low dosis Gonadotrophin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 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: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard dosis protocol<br>Administration of standard dosis of gonadotrophins for ovarian stimulation. | Drug: Gonadotrophins<br>* Administration of standard ovarian stimulation protocol<br>|
| Experimental: 2<br>Administration of low dosis of Gonadotrophins for ovarian stimulation | Drug: Low dosis Gonadotrophin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aneuploidy rate with two different stimulation protocols. |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal blastocyst rate |  | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperstimulation, Ovarian, Embryo, Aneuploidy, Ovarian hyperstimulation and Embryo Aneuploidy Rates