The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol

NCT ID: NCT01636505

Last Updated: 2012-07-10

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-09-30

Brief Summary

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The aim of this study is to performed a randomized controlled trial to evaluate the rate of genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocols.

Patients will be prospectively randomized in two groups: the first undergoing controlled ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist ovarian stimulation regimen.

The end-points of the study include the number of genetically and chromosomally abnormal embryos, the pregnancy, the implantation and the healthy baby birth rate.

The patients included in PGS program were selected on the base of advanced maternal age, repeated pregnancy lost and implantation failure whereas the patients who were know to carry sex-linked or monogenic disorders were considered for PGD strategy.

The uterine abnormalities, endometriosis and endocrinal diseases were considered to be the exclusion factors.

Detailed Description

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Conditions

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Embryo's Genetic and Chromosomal Quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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short protocol

gnrh agonist versus gnrh antagonist

Group Type ACTIVE_COMPARATOR

ghrh antagonist (cetrotide/orgalutran)

Intervention Type DRUG

cetrotide/orgalutran 0.25 mg

long protocol

Group Type ACTIVE_COMPARATOR

gnrh agonist (suprefact)

Intervention Type DRUG

suprefact 5.5 ml

Interventions

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ghrh antagonist (cetrotide/orgalutran)

cetrotide/orgalutran 0.25 mg

Intervention Type DRUG

gnrh agonist (suprefact)

suprefact 5.5 ml

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients carrier genetic disease
* advanced maternal Age
* repeated IVF failure
* recurrent pregnancy loss

Exclusion Criteria

* uterine abnormalities
* endometriosis
* endocrinal diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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European Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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European Hospital

Rome, , Italy

Site Status

Countries

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Italy

Facility Contacts

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Ermanno Greco, MD

Role: primary

Other Identifiers

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ECK011170

Identifier Type: -

Identifier Source: org_study_id