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
Information provided by (Responsible Party):
European Hospital Identifier:
First received: July 5, 2012
Last updated: July 9, 2012
Last verified: July 2012

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.

Condition Intervention Phase
Embryo's Genetic and Chromosomal Quality
Drug: ghrh antagonist (cetrotide/orgalutran)
Drug: gnrh agonist (suprefact)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening

Resource links provided by NLM:

Further study details as provided by European Hospital:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: short protocol
gnrh agonist versus gnrh antagonist
Drug: ghrh antagonist (cetrotide/orgalutran)
cetrotide/orgalutran 0.25 mg
Active Comparator: long protocol Drug: gnrh agonist (suprefact)
suprefact 5.5 ml


Ages Eligible for Study:   18 Years to 46 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • uterine abnormalities
  • endometriosis
  • endocrinal diseases
  Contacts and Locations
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Please refer to this study by its identifier: NCT01636505

European Hospital Not yet recruiting
Rome, Italy, 00148
Contact: Ermanno Greco, MD    06-65975643   
Principal Investigator: Ermanno greco, MD         
Sponsors and Collaborators
European Hospital
  More Information

No publications provided

Responsible Party: European Hospital Identifier: NCT01636505     History of Changes
Other Study ID Numbers: ECK011170
Study First Received: July 5, 2012
Last Updated: July 9, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on November 27, 2015