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

• Sponsor: European Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01636505
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 16.7

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Study Start Date: Sep 1, 2012
• Anticipated Primary Completion Date: Feb 1, 2013
• Anticipated Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol [one year]

   difference in embryos' genetic and chromosomal quality using two different ovarian stimulation protocol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 46 Years
• Sexes 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

Locations

	Site	City	State	Country	Postal Code
1	European Hospital	Rome		Italy	00148

Sponsors and Collaborators

• European Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: European Hospital
• ClinicalTrials.gov Identifier: NCT01636505
• Other Study ID Numbers: ECK011170
• First Posted: Jul 10, 2012
• Last Update Posted: Jul 10, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Cetrorelix; Buserelin; Ganirelix

Study Results

No Results Posted as of Jul 10, 2012