← Back to all trials
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.
Source: ClinicalTrials.gov (NCT07779850). StuddyBuddy aggregates publicly available trial information.