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

This study is not yet open for participant recruitment.

Verified July 2012 by European Hospital

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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 5, 2012
Last Updated Date	July 9, 2012
Start Date ^ICMJE	September 2012
Estimated Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 9, 2012)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01636505 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol
Official Title ^ICMJE	Not Provided
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening
Condition ^ICMJE	Embryo's Genetic and Chromosomal Quality
Intervention ^ICMJE	Drug: ghrh antagonist (cetrotide/orgalutran) cetrotide/orgalutran 0.25 mg Drug: gnrh agonist (suprefact) suprefact 5.5 ml
Study Arm (s)	Active Comparator: short protocol gnrh agonist versus gnrh antagonist Intervention: Drug: ghrh antagonist (cetrotide/orgalutran) Active Comparator: long protocol Intervention: Drug: gnrh agonist (suprefact)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	September 2013
Estimated Primary Completion Date	February 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: patients carrier genetic disease advanced maternal Age repeated IVF failure recurrent pregnancy loss Exclusion Criteria: uterine abnormalities endometriosis endocrinal diseases
Gender	Female
Ages	18 Years to 46 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01636505
Other Study ID Numbers ^ICMJE	ECK011170
Has Data Monitoring Committee	No
Responsible Party	European Hospital
Study Sponsor ^ICMJE	European Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	European Hospital
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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