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Clinical Trials/NCT01636505
NCT01636505
Unknown
Phase 3

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

European Hospital1 site in 1 country200 target enrollmentSeptember 2012

Overview

Phase
Phase 3
Intervention
ghrh antagonist (cetrotide/orgalutran)
Conditions
Embryo's Genetic and Chromosomal Quality
Sponsor
European Hospital
Enrollment
200
Locations
1
Primary Endpoint
The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
September 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
European Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • uterine abnormalities
  • endometriosis
  • endocrinal diseases

Arms & Interventions

short protocol

gnrh agonist versus gnrh antagonist

Intervention: ghrh antagonist (cetrotide/orgalutran)

long protocol

Intervention: gnrh agonist (suprefact)

Outcomes

Primary Outcomes

The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol

Time Frame: one year

difference in embryos' genetic and chromosomal quality using two different ovarian stimulation protocol

Study Sites (1)

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