drugset / Trial / NCT02999958

Adding Antioxidants Into Human Sequential Culture Media System

NCT02999958

Completed 128 enrolled Vitrolife
RandomizedParallel-groupDouble-blindTreatment

Summary

Upon collection, human oocytes are fertilized and culture up to the blastocyst stage, followed by transfer and / or cryopreservation. Culture media systems have been developed that support each step of this process. Although these culture media systems try to mimic the natural environment, several components of the in-vivo situation are not present in today´s media. One such component is anti-oxidants that may protect embryos against damage by reactive oxygen species. This investigation aims to compare blastocyst development using 2 different types of culture media systems, one of which contains antioxidants. Patients having at least eight oocytes and meeting other inclusion criteria can be included in this investigation. It is a prospective randomized multicenter study randomly dividing oocytes into two groups and assessing parameters of embryo development from fertilization up to blastocyst formation until day six. Embryos with acceptable developmental characteristics can be transferred into the uterus or cryopreserved for later use. The investigation is designed as a superiority study comparing utilization rate of blastocysts per normally fertilized oocyte using both media systems. In patients receiving embryo transfer in the fresh treatment cycle, detection of clinical pregnancy by ultrasound after 12 weeks gestation is the final endpoint of the investigation.

Timeline

Start
2016-12
Primary completion
2018-05
Completion
2018-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetylcarnitine Small molecule
Comparator N-acetylcysteine Small molecule
Comparator alpha-lipoic acid Small molecule

Indications

No indication recorded.