Aneuploidies and Different Stimulation Protocols

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-04-30

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).

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Detailed Description

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Conditions

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Aneuploidy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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standard dosis protocol

Administration of standard dosis of gonadotrophins for ovarian stimulation.

Group Type ACTIVE_COMPARATOR

Gonadotrophins

Intervention Type DRUG

Administration of standard ovarian stimulation protocol

2

Administration of low dosis of Gonadotrophins for ovarian stimulation

Group Type EXPERIMENTAL

Low dosis Gonadotrophin

Intervention Type DRUG

Interventions

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Gonadotrophins

Administration of standard ovarian stimulation protocol

Intervention Type DRUG

Low dosis Gonadotrophin

Intervention Type DRUG

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