drugset / Trial / NCT02971878

Comparisons of Human Embryonic Development Using Single Medium With and Without the Addition of Antioxidants

NCT02971878

RandomizedParallel-groupTriple-blindTreatment

Summary

Aim: To investigate the impact of antioxidants (acetyl-L-carnitine, N-acetyl-L-cysteine and a-lipoic acid) on embryo development and subsequently the clinical outcome. Including clinics using low oxygen and ambient air during embryo culture. Analysed with time-lapse system. Study media: G-TL with antioxidants. Control media: Same media without antioxidants. Type of study: Study comparing blastocyst development on the same cohort of oocytes using two different media, G-TL versus G-TL supplemented with antioxidants. Statistics based on an absolute increase in Good Quality Blastocysts on day 5 of 7%. Design: Multicentre prospective randomized sibling trial. Single blastocyst transfer. Superiority study Primary Endpoint: Good Quality Blastocysts on day 5 per allocated normally fertilized oocyte. Patients: Comparative embryo sibling study with 128 patients included.

Timeline

Start
2016-11
Primary completion
2018-02-01
Completion
2018-02-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetylcarnitine Small molecule
Comparator N-acetylcysteine Small molecule
Comparator α-lipoic acid Unknown

Indications

No indication recorded.