The Effects of Acetyl-L-Carnitine and Myo/Chiro-Inositol in Patients With PCOS

What Was Tested

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

The large number of women in their child bearing age is affected by Polycystic ovarian syndrome (PCOS) leading to infertility.

However it is considered as a multisystem disorder with comorbidities rather than a gynecological and a dermatological problem.

Patient mostly have anovulation presented as oligomennorhea or amenorrhea and hyperandrogenism presented as hirsutism along with hyperinsulinemia and insulin resistance.

It had four arms (groups): Metformin Group (active comparator), Inositol isomers Group (experimental), Acetyl-L- Carnitine Group (experimental) and Combine Group (experimental).

The registry classes the interventions as drug.

More on the Plan

Introduction A tremendously high number of women in their child bearing age is affected by Polycystic ovarian syndrome (PCOS) leading to infertility (1).

PCOS is not a simple gynecological or dermatological problem but a multisystem disorder with comorbidities.

Patients mostly have anovulation presented as oligomennorhea or amenorrhea and hyperandrogenism presented with symptoms of hirsutism along with hyperinsulinemia and insulin resistance.

The presence of multiple cysts in the ovaries however, is not essential for diagnosis (2).

Who Took Part

The registry lists 120 actual participants took part.

It was open to women only aged from 18 years up to 35 years.

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

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

Groups ran in parallel: each of the pcos participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and investigator.

It started in 2023-07-15 with completion listed for 2024-02-25.

It ran at 1 site in Pakistan.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): CLINICAL PREGNANCY (time frame: 6 MONTHS).

It also tracked 4 secondary outcomes, for example OVULATION, Conception, Biochemical Pregnancy and tetosterone levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 120 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.