Embryo Aneuploidies and Ovarian Stimulation

NCT ID: NCT00707525

Last Updated: 2010-03-26

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

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-02-28

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.

Detailed Description

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Conditions

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Embryo Aneuploidies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Natural cycle oocyte donation

Group Type NO_INTERVENTION

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.

Group Type ACTIVE_COMPARATOR

Preimplantation Genetic Diagnosis

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 to 35 years old.
* 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

* Endometriosis
* Policystic ovarian syndrome
* Recurrent miscarriages.


* Uterine disease (polyps, myomas, mullerian defects)
* Recurrent miscarriages.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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Instituto Valenciano de Infertilidad, Spain

Locations

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Instituto Valenciano de Infertilidad

Valencia, Valencia, Spain

Site Status

Countries

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Spain

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.

Reference Type DERIVED
PMID: 22865900 (View on PubMed)

Other Identifiers

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0607-C-M09-EL

Identifier Type: -

Identifier Source: org_study_id

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