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Studying the effect of empagliflozin and metformin in women with polycystic ovary syndrome

Comparison of the Therapeutic effect of Empagliflozin and Metformin in Patients with Polycystic Ovary Syndrome (PCOS ) Undergoing Intracytoplasmic Sperm Injection (ICSI)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210210050315N1
Enrollment
60
Registered
2024-12-02
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Control group: 20 PCOS patients received oral rehydration solution (ORS) at a dose of 25 mg once a day orally for 8 weeks. This solution contains water, sugar, and salt (electrolytes),

Sponsors

Arak University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 40 Years

Inclusion criteria

Inclusion criteria: Menstrual disorders including oligomenorrhea or anovulation Hirsutism Infertility ultrasound findings of enlarged ovaries and multiple follicles measuring 2-10 mm, increased LH/FSH ratio high AMH levels hyperandrogenism normal thyroid function prolactin levels normal sperm analysis of the partner

Exclusion criteria

Exclusion criteria: Resistance to metformin or empagliflozin or using effective drugs in the metabolism of carbohydrates Hyperprolactinemia Cushing syndrome Congenital adrenal hyperplasia Thyroid gland disorder Severe liver or kidney diseases Abnormal sperm parameters in one's spouse

Design outcomes

Primary

MeasureTime frame
Evaluation of biochemical factors. Timepoint: Before taking the drug and 8 weeks after starting to take the drug. Method of measurement: Biochemical kits using ELISA method.;Measurement of hormone levels. Timepoint: Before taking the drug and 8 weeks after starting to take the drug. Method of measurement: Hormonal kits using the ELISA method.

Secondary

MeasureTime frame
Examination of oocyte quality. Timepoint: After completing the intervention. Method of measurement: Examining the morphology of ovules and embryos using an inverted microscope.;Molecular studies. Timepoint: 8 weeks after starting the medication. Method of measurement: Use of real time polymerase chain reaction kit and device (Real time PCR).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSonieshargh Shima

Arak University

soniesharghshima@yahoo.com+98 21 7745 3089

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026