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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

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
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636505

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

No publications provided

Responsible Party: European Hospital
ClinicalTrials.gov 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:
Buserelin
Ganirelix
Cetrorelix
Deslorelin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013