An interventional study of Myo-Inositol and Folic Acid in Polycystic Ovary Syndrome, sponsored by Kafrelsheikh University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment
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).
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 88 is above the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received myo-inositol 600 mg combined with folic acid 0.24 mg twice daily for 3 months before starting the assisted reproductive technology (ART) cycle and continued treatment until the day of oocyte retrieval.
Dietary Supplement: Myo-Inositol
Participants received folic acid 0.24 mg for 3 months before starting the assisted reproductive technology (ART) cycle and continued treatment until the day of oocyte retrieval.
Dietary Supplement: Folic Acid
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.
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
Plan to share: No
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Inositol