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

What Was Tested

The trial (phase 3) is built around Buserelin.

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.

It had two arms (groups): short protocol (active comparator) and long protocol (active comparator).

Gnrh agonist versus gnrh antagonist.

The registry classes the interventions as drug.

Who Took Part

200 planned participants were the target.

It was open to women only aged from 18 years up to 46 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients carrier genetic disease. Advanced maternal Age. Repeated IVF failure. Recurrent pregnancy loss.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: uterine abnormalities; endocrinal diseases.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Buserelin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Buserelin study: the participants and staff both knew the treatment.

It started in 2012-09 with completion listed for 2013-02.

It ran at 1 site in Italy.

Its stated primary purpose is screening.

What Was Measured

The main thing measured (primary outcome): 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).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Buserelin in 200 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Buserelin compound page, all human trials.