L-carnitine and COH in PCOS Women Undergoing IVF/ICSI Cycles

What Was Tested

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

The aim of this study was to evaluate the effect of oral L-carnitine supplementation during controlled ovarian stimulation (COS) in patients with polycystic ovary syndrome (PCOS) in a double-blind randomized clinical trial.

It had two arms (groups): Adding l-carnitine to controlled ovarian stimulation antagonist protocol (experimental) and Adding placebo to controlled ovarian stimulation antagonist protocol (placebo comparator).

The controlled ovarian stimulation procedure in all the study participate will be same by using a flexible regimen of GnRH antagonist with E2 priming. The patients in the control group will receive 3 placebo tablets in similar way for 8 weeks.

The registry classes the interventions as drug.

More on the Plan

Prior to the onset of ovarian stimulation, patients will be allocated randomly into two groups according to block randomization method.

The methodologist will give the doctor a code according to the randomization list, which corresponds to the code on the drug's box, and the drug box will be delivered to the patient.

The COS procedure in all the study participate will be same by using a flexible regimen of GnRH antagonist with E2 priming.

The patients in control group will receive 3 placebo tablets for 8 weeks.

Who Took Part

Enrollment: 110 actual participants took part.

It was open to women only aged from 20 years up to 37 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 0 inclusion and 5 exclusion criteria; among the exclusions: patients diagnosed with hyperprolactinemia, diabetes mellitus, epilepsy; patients treated with special diet, medication supplement (ovuboost), metformin before or during ovarian stimulation; history of pelvic surgery on ovaries and uterus.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The pcos participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

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

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

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

It started in 2020-03-01 with completion listed for 2022-12-29.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Occyte maturity rate (time frame: 24 hours post oocyte retrieval day).

It also tracked 5 secondary outcomes, for example Fertilization rate, Quality of obtained embryos, Implantation rate, Clinical pregnancy rate and ongoing pregnancy rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 110 people with pcos.

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, PCOS research.