Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women

NCT03585738 | Not Yet Recruiting DMC

• 1 other identifier: IPOSI-1
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Inositol; Polycystic ovarian syndrome; Pregnancy; Obstetrics outcomes; Gestational diabetes; Preeclampsia

Outcome Measures

Primary Outcomes (4)

• Gestational diabetes prevalence

  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).

  During pregnancy at 16-18 week or 24-28 weeks as recommended

• Preeclampsia prevalence

  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.

  During pregnancy after the 20 week of gestation

• Birth weight

  gr

  At delivery.

• Weight gain in pregnancy

  Kg

  Change in weight before pregnancy and at the 38 week of gestation

Study Arms (2)

Inositol + Folic acid

EXPERIMENTAL

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

Folic acid

PLACEBO COMPARATOR

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

Interventions

Inositol + Folic acid DIETARY_SUPPLEMENT

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

Inositol + Folic acid

Folic acid DIETARY_SUPPLEMENT

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

Folic acid

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead
• Universita di Verona: collaborator

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Diabetes, Gestational; Pre-Eclampsia

Interventions

Inositol; Folic Acid

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypertension, Pregnancy-Induced

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Antonio Simone Laganà, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Simone Garzon, M.D.

  Univerisity of Verona

  PRINCIPAL INVESTIGATOR

• Fabio Ghezzi, M.D.

  Università degli Studi dell'Insubria

  STUDY CHAIR

• Massimo Franchi, M.D.

  Univerisity of Verona

  STUDY CHAIR

• Antonella Cromi, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Simone Laganà, M.D.

CONTACT

+39 329 6279579; antoniosimone.lagana@asst-settelaghi.it

Simone Garzon, M.D.

CONTACT

+39 347 0782287; simone.garzon@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized multi centre double-blind controlled trial

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 13, 2018
• Study Start: January 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 5, 2020

Record last verified: 2020-11