Myoinositol vs. Metformin for Polycystic Ovarian Syndrome (PCOS): Impact on Metabolic Health and Fertility

Benha University

Status: Completed

Conditions: PCOS

Treatments: Drug: Metformin Hydrochloride 500 MG; Drug: Myoinositol

Study type: Interventional

Funder types: Other

Identifiers

NCT07058675

RC 1-11-2024

Details and patient eligibility

About

The study aimed to assess how a 6-month insulin sensitizer therapy impacts insulin resistance, glucose tolerance, and hormonal levels in women with PCOS. Researchers evaluated 156 PCOS patients, measuring their BMI, HOMA-IR (for insulin resistance), TyG index, TyG index-BMI, and total testosterone. Participants were divided into two groups, receiving either metformin or a myoinositol/d-chiro-inositol combination for six months, after which all parameters were re-evaluated to determine the percentage of change.

Enrollment: 156 patients

Sex: Female

Ages: 23 to 47 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting manifestations suggestive of having PCOS;
• Patients were free of exclusion criteria.

Exclusion criteria

• Patients who were maintained on a diet regimen, or/and regular exercise;
• Patients who were on medical therapy of PCOS, antidiabetic or/and antihypertensive therapy;
• Patients who underwent laparoscopic drilling;
• Patients with dyslipidemia, hereditary lipoprotein disorders:
• Patients with chronic liver or kidney diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

156 participants in 2 patient groups

Myoinositol Group

Active Comparator group

Description:

Patients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took the tablets containing myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratio

Treatment:

Drug: Myoinositol

Metformin Group

Active Comparator group

Description:

Patients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took metformin (MET) hydrochloride 500 mg

Treatment:

Drug: Metformin Hydrochloride 500 MG