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

What Was Tested

The trial (not phased) is built around L-Carnitine.

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.

Study media: G-TL with antioxidants.

It had two arms (groups): Control (no intervention) and Treatment (active comparator).

Culture media without addition of antioxidants.

Culture media with the addition of antioxidants.

The registry classes the interventions as biological.

More on the Plan

Study objective: Study comparing blastocyst development on the same cohort of oocytes using two different media, G-TL versus G-TL supplemented with antioxidants.

Primary endpoint: Percentage of good quality blastocysts (GQB) per fertilized oocyte on day 5.

Power analysis The planning and the power analysis was made together with a statistician, Nils-Gunnar Pehrsson.

Randomization Couples will be enrolled in the study after fertilization check (day 1).

Who Took Part

128 actual participants took part.

It was open to people of any sex aged from 20 years up to 41 years.

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

Examples of who could join: Couples with female, male or unexplained infertility intending to undergo IVF. The couple should have received verbal and written information/consent about the study. 6 or more fertilized oocytes on day 1. Blastocyst culture and transfer on day 5. Signed written consent.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: previous participation in the study; testicular biopsy patients (tesa/tese); fewer than 6 fertilized oocytes.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The L-Carnitine group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2016-11 with completion listed for 2018-02-01.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of good quality blastocysts (GQB) per randomized embryo (time frame: 7 months).

It also tracked 6 secondary outcomes, for example Pregnancy rate, Utilization rate, Embryo development (Kinetics) day 3,5 & 6, Implantation rate, Embryo quality dag 3,5 and 6 and Total blastocyst rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 128 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.