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

Primary Purpose

Polycystic Ovary Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inositol + Folic acid
Folic acid
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Inositol, Polycystic ovarian syndrome, Pregnancy, Obstetrics outcomes, Gestational diabetes, Preeclampsia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Inositol + Folic acid

    Folic acid

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).
    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.
    Birth weight
    gr
    Weight gain in pregnancy
    Kg

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2018
    Last Updated
    November 3, 2020
    Sponsor
    Università degli Studi dell'Insubria
    Collaborators
    Universita di Verona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03585738
    Brief Title
    Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women
    Acronym
    IPOSI-1
    Official Title
    Effects of Oral Inositol Supplementation on Obstetrics Outcomes in Polycystic Ovary Syndrome Women After Spontaneous Conception
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Università degli Studi dell'Insubria
    Collaborators
    Universita di Verona

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome
    Keywords
    Inositol, Polycystic ovarian syndrome, Pregnancy, Obstetrics outcomes, Gestational diabetes, Preeclampsia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized multi centre double-blind controlled trial
    Masking
    ParticipantCare ProviderInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Inositol + Folic acid
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Folic acid
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Inositol + Folic acid
    Intervention Description
    Daily oral supplementation before spontaneous conception until delivery: Myo-Inositol: 1100 mg D-chiro-inositol: 27.6 mg Folic acid: 400 mcg
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Folic acid
    Intervention Description
    Daily oral supplementation before spontaneous conception until delivery: Folic acid: 400 mcg
    Primary Outcome Measure Information:
    Title
    Gestational diabetes prevalence
    Description
    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).
    Time Frame
    During pregnancy at 16-18 week or 24-28 weeks as recommended
    Title
    Preeclampsia prevalence
    Description
    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.
    Time Frame
    During pregnancy after the 20 week of gestation
    Title
    Birth weight
    Description
    gr
    Time Frame
    At delivery.
    Title
    Weight gain in pregnancy
    Description
    Kg
    Time Frame
    Change in weight before pregnancy and at the 38 week of gestation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Antonio Simone Laganà, M.D.
    Phone
    +39 329 6279579
    Email
    antoniosimone.lagana@asst-settelaghi.it
    First Name & Middle Initial & Last Name or Official Title & Degree
    Simone Garzon, M.D.
    Phone
    +39 347 0782287
    Email
    simone.garzon@univr.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antonio Simone Laganà, M.D.
    Organizational Affiliation
    Università degli Studi dell'Insubria
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Simone Garzon, M.D.
    Organizational Affiliation
    Univerisity of Verona
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Fabio Ghezzi, M.D.
    Organizational Affiliation
    Università degli Studi dell'Insubria
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Massimo Franchi, M.D.
    Organizational Affiliation
    Univerisity of Verona
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Antonella Cromi, M.D.
    Organizational Affiliation
    Università degli Studi dell'Insubria
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women

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