IPOSI-1: Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women

• Sponsor: Università degli Studi dell'Insubria (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03585738
• Collaborator: Universita di Verona (Other)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 60

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Dietary Supplement: Inositol + Folic acid; Dietary Supplement: Folic acid	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized multi centre double-blind controlled trialRandomized multi centre double-blind controlled trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: The patients, care provides, investigators and outcome assessors are blinded for the treatment: Inositol + Folic acid versus Folic acid alone. The treatment allocation is identified by code number before the study start, and will be revealed only after data analysis.
• Primary Purpose: Treatment
• Official Title: Effects of Oral Inositol Supplementation on Obstetrics Outcomes in Polycystic Ovary Syndrome Women After Spontaneous Conception
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inositol + Folic acid Couples with PCOS infertile women, diagnosed according to the Rotterdam criteria, who access infertility center with conception desire. These women will receive oral supplementation with Inositol (Myo-inositol and D-chiro-inositol at 40:1 ratio) plus Folic acid before spontaneous conception until delivery.	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
Placebo Comparator: Folic acid Couples with PCOS infertile women, diagnosed according to the Rotterdam criteria, who access infertility center with conception desire. These women will receive oral supplementation with Folic acid before spontaneous conception until delivery.	Dietary Supplement: Folic acid; Daily oral supplementation before spontaneous conception until delivery: Folic acid: 400 mcg

Outcome Measures

Primary Outcome Measures

1. Gestational diabetes prevalence [During pregnancy at 16-18 week or 24-28 weeks as recommended]

   Gestational diabetes prevalence: number of women that develop gestational diabetes diagnosed based on oral glucose tolerance test (OGTT) cut-off (92 - 180 - 153 mg/dl).

2. Preeclampsia prevalence [During pregnancy after the 20 week of gestation]

   Preeclampsia prevalence: number of women that develop preeclampsia diagnosed based on blood pressure higher than 140/90 mmHg after 20 week of gestation plus 24h proteinuria higher that 300mg.

3. Birth weight [At delivery.]

   gr

4. Weight gain in pregnancy [Change in weight before pregnancy and at the 38 week of gestation]

   Kg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pregnancy spontaneously conceived in women with PCOS diagnosed by Rotterdam criteria that starts oral supplementation before conception.

Exclusion Criteria:

• Any kwon pre-pregnancy disease.

• Any other pharmacological, non-pharmacological or nutraceutical treatment (beside oral folic acid supplementation) more than 3 months before the enrollment (wash-out period) or during the trial, or until the development or pregnancy-induced/related diseases requiring pharmacological treatments.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Università degli Studi dell'Insubria
• Universita di Verona

Investigators

• Principal Investigator: Antonio Simone Laganà, M.D., Università degli Studi dell'Insubria
• Principal Investigator: Simone Garzon, M.D., Univerisity of Verona
• Study Chair: Fabio Ghezzi, M.D., Università degli Studi dell'Insubria
• Study Chair: Massimo Franchi, M.D., Univerisity of Verona
• Principal Investigator: Antonella Cromi, M.D., Università degli Studi dell'Insubria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
• ClinicalTrials.gov Identifier: NCT03585738
• Other Study ID Numbers: IPOSI-1
• First Posted: Jul 13, 2018
• Last Update Posted: Nov 5, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria: Inositol; Polycystic ovarian syndrome; Pregnancy; Obstetrics outcomes; Gestational diabetes; Preeclampsia
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Folic Acid; Vitamin B Complex; Inositol

Study Results

No Results Posted as of Nov 5, 2020