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Completed NCT07779850

Myo-Inositol for Ovarian Stimulation and ICSI Outcomes in Women With PCOS

Conditions: Polycystic Ovary Syndrome

Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 88
Sponsor: Kafrelsheikh University

Location: Kafr-Elsheikh University Hospital Kafr ash Shaykh Kafr el-Sheikh Governorate

Summary

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).

Eligibility Criteria

Inclusion Criteria: * Female participants aged 18 to 40 years. * Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria. * Normal thyroid hormone levels. * Normal prolactin levels. * Candidates for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). Exclusion Criteria: * Previous ovarian surgery. * History of endometrioma. * History of endocrine disease, including congenital adrenal hyperplasia or diabetes mellitus. * Smoking. * Known allergy to myo-inositol. * Current use of oral contraceptive pills. * Receipt of hormonal medications within the 3 months before study enrollment. * Refusal to participate in the study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07779850). StuddyBuddy aggregates publicly available trial information.