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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
134
Myo-inositol and Folic acid daily
Folic Acid daily
Universitair Ziekenhuis Brussel
Brussels, Belgium
RECRUITINGSerum testosterone level after 12 weeks of administration of Myo-Inositol
Time frame: 2 years
Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol
Time frame: 2 years
Number of mature oocytes
Time frame: 2 years
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).
Time frame: 2 years
Implantation rate (%)
Time frame: 2 years
Clinical pregnancy rate (%)
Time frame: 2 years
Live birth rate in fresh cycle
Time frame: 2 years
Cumulative live birth rate after 1 cycle
Time frame: 2 years
Ovarian Hyperstimulation Syndrome rate
Time frame: 2 years
Consumption of gonadotrophins
measurement in IU
Time frame: 2 years
Stimulation days
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measurement in days
Time frame: 2 years