Polycystic ovary syndrome (PCOS) is a common endocrine disorder that may affect ovarian function, insulin sensitivity, and fertility. Myo-inositol has been proposed as an insulin-sensitizing supplement that may improve metabolic and reproductive outcomes in women with PCOS. This randomized, double-blind clinical trial evaluated the effect of myo-inositol supplementation on controlled ovarian stimulation and assisted reproductive technology (ART) outcomes in women with PCOS undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). A total of 88 participants were randomly assigned to two parallel groups. The intervention group received myo-inositol combined with folic acid, while the control group received folic acid alone for 3 months before the ART cycle and until the day of oocyte retrieval. The study assessed whether myo-inositol could improve metabolic and hormonal parameters, ovarian response to stimulation, oocyte and embryo quality, and pregnancy outcomes, while also evaluating ovarian hyperstimulation syndrome (OHSS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
Myo-inositol was administered as 600 mg capsules in combination with folic acid 0.24 mg twice daily. Supplementation was started 3 months before the assisted reproductive technology (ART) cycle and continued until the day of oocyte retrieval.
Folic acid 0.24 mg was administered for 3 months before initiation of the assisted reproductive technology (ART) cycle and continued until the day of oocyte retrieval.
Kafr-Elsheikh University Hospital
Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt
Mean Number of Immature and Degenerated Oocytes (GV-DEG)
Mean number of immature and degenerated oocytes, including germinal vesicle and degenerated (GV-DEG) oocytes, obtained from each participant following controlled ovarian stimulation. This outcome was used as the primary endpoint for the sample size calculation.
Time frame: At oocyte retrieval, after approximately 3 months of assigned supplementation
Number of Mature Metaphase II (MII) Oocytes
Number of mature metaphase II (MII) oocytes obtained from each participant at oocyte retrieval.
Time frame: At oocyte retrieval, approximately 3 months after initiation of assigned supplementation
Number of Fertilized Oocytes
Number of injected oocytes that achieved fertilization following in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI).
Time frame: At fertilization assessment, approximately 16-18 hours after IVF/ICSI and within 1 day after oocyte retrieval
Embryo Quality
Embryo quality was assessed according to European Society of Human Reproduction and Embryology (ESHRE) morphological criteria based on blastomere regularity, degree of fragmentation, and multinucleation. Embryos were classified into Grades 1, 2, and 3.
Time frame: 44 to 48 hours after fertilization
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