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

Embryo's Genetic and Chromosomal Quality Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01636505
• Other study ID #: ECK011170
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 5, 2012
• Last updated: July 9, 2012
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2012
• Source: European Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 46 Years

Eligibility

Inclusion Criteria:

• patients carrier genetic disease

• advanced maternal Age

• repeated IVF failure

• recurrent pregnancy loss

Exclusion Criteria:

• uterine abnormalities

• endometriosis

• endocrinal diseases

Study Design

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

Related Conditions & MeSH terms

• Embryo's Genetic and Chromosomal Quality

Intervention

Drug:
• ghrh antagonist (cetrotide/orgalutran)
cetrotide/orgalutran 0.25 mg
• gnrh agonist (suprefact)
suprefact 5.5 ml

Locations

Country	Name	City	State
Italy	European Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
European Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol	difference in embryos' genetic and chromosomal quality using two different ovarian stimulation protocol	one year	Yes