Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women

Summary

Polycystic ovarian syndrome (PCOS) is a heterogeneous, multifaceted and complex disorder characterized by insulin resistance (IR), hyperinsulinemia, and hyperandrogenism leading ovarian disfunction and infertility. Given the central pathogenic role of IR in the endocrine, reproductive, and metabolic disturbances of PCOS, several pharmacological and non-pharmacological approaches have been proposed to counteract the hyper insulinemic IR typical of the syndrome. Two Inositol stereoisomers, Myo-Inositol (MI) and D-chiro-inositol (DCI), captured the attention of researchers for their insulin-sensitizing actions, which configure them as proper candidates for the treatment of PCOS.

Very few studies reported on spontaneous clinical pregnancy rates, none were powered for this outcome, and none reported on the clinically relevant outcome of live birth. Therefore, data about clinical pregnancy rate, live birth rate, and miscarriage rate comparing inositols with placebo are limited.

Nevertheless, regarding infertility the primary outcomes that should be considered are clinical pregnancy rate, miscarriage rate and live birth rate. Although many studies showed improved hormonal and metabolic profile and improved ovulation rate and higher quality and number of oocyte retrieved in Assisted Reproductive Technology (ART) in PCOS women after inositols administration, data about clinical pregnancy rate, live birth rate, and miscarriage rate are limited with several concerns regarding interpretation of the studies.

Furthermore, independently by the effect on PCOS related infertility, few data are available about the role of inositol on obstetrics outcomes of pregnancies conceived after treatment with inositol and/or orally supplemented during pregnancy. Considering that the combination of MI and DCI alleviate many of the metabolic dysregulations typical of PCOS thanks to insulin-sensitizing actions, it is plausible consider a beneficial effects on pregnancy complications such as gestational diabetes and preeclampsia.

Conditions

• Polycystic Ovary Syndrome

Interventions

DIETARY_SUPPLEMENT

Inositol + Folic acid

Daily oral supplementation before spontaneous conception until delivery: Myo-Inositol: 1100 mg D-chiro-inositol: 27.6 mg Folic acid: 400 mcg

DIETARY_SUPPLEMENT

Folic acid

Daily oral supplementation before spontaneous conception until delivery: Folic acid: 400 mcg

Sponsors & Collaborators

• Universita di Verona

  collaborator OTHER

• Università degli Studi dell'Insubria

  lead OTHER

Principal Investigators

• Antonio Simone Laganà, M.D. · Università degli Studi dell'Insubria

• Simone Garzon, M.D. · Univerisity of Verona

• Fabio Ghezzi, M.D. · Università degli Studi dell'Insubria

• Massimo Franchi, M.D. · Univerisity of Verona

• Antonella Cromi, M.D. · Università degli Studi dell'Insubria

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2024-12-31

Completion

2026-12-31