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Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients

Pretreatment With Myo-inositol in Hyperandrogenic PCOS Patients Undergoing ART: a Randomized Controlled Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03767569
Enrollment
134
Registered
2018-12-06
Start date
2018-09-01
Completion date
2020-04-30
Last updated
2018-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Infertility, PCOS

Brief summary

A randomized controlled trial to evaluate whether pretreatment with myo-inositol can lower testosterone levels and improve clinical outcomes in hyperandrogenic PCOS patients undergoing ART

Interventions

DRUGMyo-inositol

Myo-inositol and Folic acid daily

DRUGFolic Acid

Folic Acid daily

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Women aged 18-40 years * PCOS phenotypes A, B and C * Signed informed consent

Exclusion criteria

* Other relevant endocrine disorders * Contraindications to the use of gonadotropins * Endometriosis grade 3-4 * BMI \> 35

Design outcomes

Primary

MeasureTime frame
Serum testosterone level after 12 weeks of administration of Myo-Inositol2 years

Secondary

MeasureTime frameDescription
Number of mature oocytes2 years—
Embryo quality2 yearsDay 3 embryos will be classified as transferable or cryopreservable/ 'good-quality embryos' (GQE) according to the criteria described by Van Landuyt et al. (2013). Blastocysts will be categorized according to Gardner et al. (1998) and Gardner and Schoolcraft (1999).
Implantation rate (%)2 years—
Clinical pregnancy rate (%)2 years—
Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol2 years—
Cumulative live birth rate after 1 cycle2 years—
Ovarian Hyperstimulation Syndrome rate2 years—
Consumption of gonadotrophins2 yearsmeasurement in IU
Stimulation days2 yearsmeasurement in days
Live birth rate in fresh cycle2 years—

Countries

Belgium

Contacts

Primary ContactMichel De Vos, PhD
michel.devos@uzbrussel.be+3224776699
Backup ContactSylvie De Rijdt, MD
sylvie.derijdt@uzbrussel.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026