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

Phase 3

• Conditions: Embryo's Genetic and Chromosomal Quality
• Interventions: Drug: gnrh agonist (suprefact); Drug: ghrh antagonist (cetrotide/orgalutran)

• Registration Number: NCT01636505
• Lead Sponsor: European Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2012-07
• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-07-09
• Last Update Submitted: 2012-07-09
• Study First Posted: 2012-07-10
• Last Update Posted: 2012-07-10
• Study Start: 2012-09
• Primary Completion: 2013-02
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• uterine abnormalities
• endometriosis
• endocrinal diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
long protocol	gnrh agonist (suprefact)	-
short protocol	ghrh antagonist (cetrotide/orgalutran)	gnrh agonist versus gnrh antagonist

Primary Outcome Measures

Name	Time	Method
The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol	one year	difference in embryos' genetic and chromosomal quality using two different ovarian stimulation protocol

Trial Locations

Locations (1)

European Hospital; 🇮🇹 Rome, Italy