Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients

Universitair Ziekenhuis Brussel

Status and phase: Unknown; Phase 3

Conditions: Female Infertility; PCOS

Treatments: Drug: Folic Acid; Drug: Myo-inositol

Study type: Interventional

Funder types: Other

Identifiers

NCT03767569

Gynositol.2018

Details and patient eligibility

About

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

Enrollment: 134 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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134 participants in 2 patient groups

Myo-inositol

Experimental group

Description:

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

Treatment:

Drug: Myo-inositol

Folic acid

Other group

Description:

Folic acid 0.4 mg daily during 12 weeks before start of ART

Treatment:

Drug: Folic Acid