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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by European Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636505
First Posted: July 10, 2012
Last Update Posted: July 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
European Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 46 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: European Hospital
ClinicalTrials.gov Identifier: NCT01636505     History of Changes
Other Study ID Numbers: ECK011170
First Submitted: July 5, 2012
First Posted: July 10, 2012
Last Update Posted: July 10, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Deslorelin
Triptorelin Pamoate
Cetrorelix
Buserelin
Ganirelix
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists