NCT03598374: IROP-1

Spontaneous Reproductive Outcomes After Oral Inositol Supplementation in Infertile Polycystic Ovarian Syndrome Women.

Status unknown NA Last updated 30 September 2021

What this trial tests

NA trial testing Inositol + Folic acid in Polycystic Ovarian Syndrome in 80 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
30 June 2023

31 December 2024

Quick facts

Lead sponsor	Università degli Studi dell'Insubria
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	1 January 2022
Primary completion	30 June 2023
Estimated completion	31 December 2024

Drugs / interventions tested

• Inositol + Folic acid
• Folic acid (FOLIC ACID) — full drug profile →
• Regular intercourses

Conditions studied

• Polycystic Ovarian Syndrome — all drugs for Polycystic Ovarian Syndrome →
• Infertility, Female — all drugs for Infertility, Female →

Sponsor

Università degli Studi dell'Insubria — full company profile →

Who can join

Adults 18 to 40, female only, with Polycystic Ovarian Syndrome or Infertility, Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Conversely, about infertility and assisted reproduction techniques (ART), improvements have been reported in PCOS women who underwent fertility treatment using inositol in different forms, combinations or doses. This data, considering the different tissue-specific ratios (i.e., 100:1 in the ovary) and the different physiological roles of inositol stereoisomers, suggest that DCI supplementation alone might not be the optimal or appropriate approach for improving IVF outcomes in PCOS patients, and drawn attention to the importance of MI and DCI supplementation in a physiological ratio in order to restore normal ovary functionality. Indeed, the combination of MI and DCI, at a more physiological ratio of 40:1, was able to more quickly restore to normal the hormonal and metabolic parameters in PCOS women than MI treatment alone or DCI treatment alone, improving the endocrine profile and IR of women with PCOS.

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 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.