Clinical trial NCT03585738: Effects of Oral Inositol Supplementation on Obstetrics Outcomes in PCOS Women
Official title: Effects of Oral Inositol Supplementation on Obstetrics Outcomes in Polycystic Ovary Syndrome Women After Spontaneous Conception
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Inositol
Polycystic ovarian syndrome
Pregnancy
Obstetrics outcomes
Gestational diabetes
Preeclampsia
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
Collaborators: name: Universita di Verona
First posted: 2018-07-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized multi centre double-blind controlled trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Gestational diabetes prevalence
timeFrame: During pregnancy at 16-18 week or 24-28 weeks as recommended
measure: Preeclampsia prevalence
timeFrame: During pregnancy after the 20 week of gestation
measure: Birth weight
timeFrame: At delivery.
measure: Weight gain in pregnancy
timeFrame: Change in weight before pregnancy and at the 38 week of gestation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Univerisity of Verona
name: Simone Garzon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Fabio Ghezzi, M.D.
role: STUDY_CHAIR
affiliation: Univerisity of Verona
name: Massimo Franchi, M.D.
role: STUDY_CHAIR
affiliation: Università degli Studi dell'Insubria
name: Antonella Cromi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: