| Registry | NCT01636505 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, screening |
| Enrollment | 200 (Estimated) |
| Sponsor | European Hospital (Other) |
| Conditions | Embryo's Genetic and Chromosomal Quality |
| Interventions | ghrh antagonist (cetrotide/orgalutran), gnrh agonist (suprefact) (Drug) |
| Dates | start 2012-09-01, primary completion 2013-02-01 (estimated), completion 2013-09-01 (estimated), first posted 2012-07-10, last updated 2012-07-10 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Embryo's Genetic and Chromosomal Quality All trials of ghrh antagonist (cetrotide/orgalutran) All trials of gnrh agonist (suprefact)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| short protocol | Active comparator | Drug: ghrh antagonist (cetrotide/orgalutran) | gnrh agonist versus gnrh antagonist |
| long protocol | Active comparator | Drug: gnrh agonist (suprefact) |
Sex: Female, ages: 18 Years to 46 Years
Inclusion Criteria: * patients carrier genetic disease * advanced maternal Age * repeated IVF failure * recurrent pregnancy loss Exclusion Criteria: * uterine abnormalities * endometriosis * endocrinal diseases
| Facility | City | Country | Status |
|---|---|---|---|
| European Hospital | Rome | Italy |