Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women
NCT ID: NCT03585738
Last Updated: 2020-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2022-01-01
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
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.
Folic acid
Daily oral supplementation before spontaneous conception until delivery:
Folic acid: 400 mcg
Interventions
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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
Folic acid
Daily oral supplementation before spontaneous conception until delivery:
Folic acid: 400 mcg
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Universita di Verona
OTHER
Università degli Studi dell'Insubria
OTHER
Responsible Party
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Antonio Simone Laganà
Principal Investigator
Principal Investigators
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Antonio Simone Laganà, M.D.
Role: PRINCIPAL_INVESTIGATOR
Università degli Studi dell'Insubria
Simone Garzon, M.D.
Role: PRINCIPAL_INVESTIGATOR
Univerisity of Verona
Fabio Ghezzi, M.D.
Role: STUDY_CHAIR
Università degli Studi dell'Insubria
Massimo Franchi, M.D.
Role: STUDY_CHAIR
Univerisity of Verona
Antonella Cromi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Università degli Studi dell'Insubria
Central Contacts
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Other Identifiers
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IPOSI-1
Identifier Type: -
Identifier Source: org_study_id