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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by European Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
European Hospital
ClinicalTrials.gov Identifier:
NCT01636505
First received: July 5, 2012
Last updated: July 9, 2012
Last verified: July 2012

July 5, 2012
July 9, 2012
September 2012
February 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
difference in embryos' genetic and chromosomal quality using two different ovarian stimulation protocol
Same as current
Complete list of historical versions of study NCT01636505 on ClinicalTrials.gov Archive Site
Not Provided
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The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Embryo's Genetic and Chromosomal Quality
  • Drug: ghrh antagonist (cetrotide/orgalutran)
    cetrotide/orgalutran 0.25 mg
  • Drug: gnrh agonist (suprefact)
    suprefact 5.5 ml
  • Active Comparator: short protocol
    gnrh agonist versus gnrh antagonist
    Intervention: Drug: ghrh antagonist (cetrotide/orgalutran)
  • Active Comparator: long protocol
    Intervention: Drug: gnrh agonist (suprefact)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
September 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • uterine abnormalities
  • endometriosis
  • endocrinal diseases
Female
18 Years to 46 Years
No
Italy
 
NCT01636505
ECK011170
No
European Hospital
European Hospital
Not Provided
Not Provided
European Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP