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

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ClinicalTrials.gov Identifier: NCT03585738
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Universita di Verona
Information provided by (Responsible Party):
Antonio Simone Laganà, Università degli Studi dell'Insubria

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2026


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





Primary Outcome Measures :
  1. Gestational diabetes prevalence [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At delivery. ]
    gr

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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585738


Contacts
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Contact: Antonio Simone Laganà, M.D. +39 329 6279579 antoniosimone.lagana@asst-settelaghi.it
Contact: Simone Garzon, M.D. +39 347 0782287 simone.garzon@univr.it

Sponsors and Collaborators
Università degli Studi dell'Insubria
Universita di Verona
Investigators
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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

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Responsible Party: Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03585738     History of Changes
Other Study ID Numbers: IPOSI-1
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antonio Simone Laganà, Università degli Studi dell'Insubria:
Inositol
Polycystic ovarian syndrome
Pregnancy
Obstetrics outcomes
Gestational diabetes
Preeclampsia

Additional relevant MeSH terms:
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Inositol
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs