This is a prospective comparative randomized controlled study investigating the effect of Myo-Inositol-based co-treatment on oocyte quality measures in women with PCOS.
Polycystic Ovary Syndrome is the most common cause of chronic anovulation in women. Women with PCOS undergoing IVF are at an increased risk for developing both multiple gestation and ovarian hyperstimulation syndrome (OHSS). Since insulin resistance and hyperinsulinemia have been implicated in the pathophysiology of the disorder, the administration of metformin before or during an IVF cycle has been practiced for years in an attempt to improve follicular parameters necessary for reproductive success. Recently, a growing body of evidence has implicated alternative insulin sensitizing drugs, namely Myo-Inositol, in improving various manifestations of the disorder in this women population. Little has been done to evaluate the effect of Myo-Inositol co-treatment on the reproductive performance of PCOS women undergoing Assisted Reproductive Technologies (ART). In this prospective comparative randomized controlled study, women will be randomized into two groups: Women in the control group will receive folic acid daily. Women in the study group will receive Myo-Inositol, in combination with alpha- lipoic acid and cysteine, per day plus folic acid supplemented daily along with ovarian stimulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients belonging to this group will receive 1 gram of Myo-Inositol, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) starting 6 weeks prior to stimulation and extending until final oocyte maturation, combined with 400 µg of folic acid supplemented daily.
American University of Beirut Medical Center
Beirut, Lebanon
RECRUITINGOocyte yield
Time frame: 1 day from ovum pick up
Maturation rate
Time frame: 1 day from ovum pick up
Fertilization rate
Time frame: 16-18 hours post insemination
Blood profile (fasting sugar and insulin levels, Testosterone, Sex Hormone-Binding protein, DHEAs, and Androstenedione)
Time frame: Prior to and 6 weeks post enrollment
Number of gonadotropin ampules
Time frame: 1 day from oocyte maturation trigger
Obstetrical outcome (preterm birth)
Time frame: From 24 to 36 weeks gestation
Obstetrical outcome (low birth weight)
Time frame: From 24 to 36 weeks gestation
Obstetrical outcome (gestational diabetes)
Time frame: From 24 to 36 weeks gestation
Obstetrical outcome (preeclampsia)
Time frame: From 24 to 36 weeks gestation
Obstetrical outcome (admission to neonatal intensive care)
Time frame: From 24 to 36 weeks gestation
Number of stimulation days
Time frame: 1 day from oocyte maturation trigger
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Embryo quality
Time frame: 3 to 5 days from ovum pick up
Miscarriage rate
Time frame: 7 weeks post LMP
Ongoing pregnancy
Time frame: 20 weeks post LMP
Live birth rate
Time frame: 24 to 42 weeks gestation