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NCT03767569 Clinical Trial

Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients

PCOS Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03767569
Other study ID # Gynositol.2018
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 1, 2018
Est. completion date April 2020

Study information
Verified date March 2018
Source Universitair Ziekenhuis Brussel
Contact Michel De Vos, PhD
Phone +3224776699
Email michel.devos@uzbrussel.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 134
Est. completion date April 2020
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Myo-inositol
Myo-inositol and Folic acid daily
• Folic Acid
Folic Acid daily

Locations
Country Name City State
Belgium Universitair Ziekenhuis Brussel Brussels

Sponsors (1)
Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum testosterone level after 12 weeks of administration of Myo-Inositol 2 years
Secondary Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol 2 years
Secondary Number of mature oocytes 2 years
Secondary Embryo quality Day 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). 2 years
Secondary Implantation rate (%) 2 years
Secondary Clinical pregnancy rate (%) 2 years
Secondary Live birth rate in fresh cycle 2 years
Secondary Cumulative live birth rate after 1 cycle 2 years
Secondary Ovarian Hyperstimulation Syndrome rate 2 years
Secondary Consumption of gonadotrophins measurement in IU 2 years
Secondary Stimulation days measurement in days 2 years
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