drugset / Trial / NCT04654741

The Rate of Embryo Euploidy in Progestin-primed Ovarian Stimulation Cycles

NCT04654741

Phase 4 Unknown 396 enrolled Casa di Cura Privata Villa Mafalda
RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of this non-inferiority randomized controlled trial is to assess the rate of blastocyst euploidy and the number of euploid blastocysts in women undergoing IVF/ICSI and treated with PPOS versus conventional ovarian stimulation based on the use of GnRH antagonist The hypothesis is that PPOS is associated with a rate of blastocyst euploidy similar to what found with the conventional ovarian stimulation. In other words, the number of euploid blastocysts that can be obtained with the PPOS strategy is expected to be the same obtained with conventional ovarian stimulation. Moreover we expect to find non significant differences in all intermediate outcome of the IVF cycles, such as in the rate of premature LH surge, in the rate of patients with elevation of Progesterone on the triggering day, in FSH consumption and length of stimulation, in the rate of poor response and hyperresponse, in number of retrieved and mature oocytes, in fertilization and blastulation rate, in the number of available blastocysts and in the morphological quality of blastocysts

Timeline

Start
2020-09-01
Primary completion
2022-02-01
Completion
2022-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ganirelix Protein / enzyme biologic 0.25 mg
Subject medroxyprogesterone acetate Other / unclassified 10 mg

Indications