Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients

Phase 3

• Conditions: PCOS; Female Infertility
• Interventions: Drug: Myo-inositol; Drug: Folic Acid

• Registration Number: NCT03767569
• Lead Sponsor: Universitair Ziekenhuis Brussel

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-04-06
• Study Start: 2018-09-01
• Study First Submitted QC: 2018-12-05
• Last Update Submitted: 2018-12-05
• Study First Posted: 2018-12-06
• Last Update Posted: 2018-12-06
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 134

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myo-inositol	Myo-inositol	Pretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology)
Folic acid	Folic Acid	Folic acid 0.4 mg daily during 12 weeks before start of ART

Primary Outcome Measures

Name	Time	Method
Serum testosterone level after 12 weeks of administration of Myo-Inositol	2 years

Secondary Outcome Measures

Name	Time	Method
Number of mature oocytes	2 years
Embryo quality	2 years	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).
Live birth rate in fresh cycle	2 years
Consumption of gonadotrophins	2 years	measurement in IU
Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol	2 years
Clinical pregnancy rate (%)	2 years
Cumulative live birth rate after 1 cycle	2 years
Ovarian Hyperstimulation Syndrome rate	2 years
Stimulation days	2 years	measurement in days
Implantation rate (%)	2 years

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium