Comparative Study of the Therapeutic Effects of Synoripa, Melijent-M, and Metformin on Anthropometric, Biochemical, and Hormonal Parameters in Women with Polycystic Ovary Syndrome Undergoing ICSI
| Author | Mahdieh Sadat Mousavi | en |
| Author | Malek Soleimani Mehranjani | en |
| Author | Forough Forghani | en |
| Author | Elnaz Salahi | en |
| Issued Date | 2026-01-31 | en |
| Abstract | Background: Polycystic ovary syndrome (PCOS) is among the most prevalent endocrine-metabolic disorders impacting individuals capable of conception. Its clinical management poses a significant challenge, particularly for those facing infertility and seeking conception through assisted reproductive technology (ART). While metformin is a cornerstone therapy, its limitations necessitate the exploration of novel combinations. Objectives: This research was conducted to assess and compare the treatment outcomes of two fixed-dose combination drugs — empagliflozin plus metformin and linagliptin plus metformin — and metformin as a single agent against an inert placebo in infertile women with PCOS scheduled for intracytoplasmic sperm injection (ICSI), aiming to identify a superior metabolic priming strategy to potentially improve the reproductive milieu prior to ART. Methods: Eighty infertile women with PCOS were randomly assigned over an 8-week period to one of four groups receiving either empagliflozin-metformin, linagliptin-metformin, metformin, or a placebo. Anthropometric, metabolic, and hormonal assessments were performed for participants in all groups two months before the ovulation induction cycle and on the day of oocyte aspiration. The primary outcome was the change in serum anti-Müllerian hormone (AMH) level. Key secondary outcomes included changes in fasting insulin, body weight, lipid profile, and other hormonal parameters (testosterone, leptin). Results: Significant decreases in body weight, Body Mass Index (BMI), and waist measurement were observed in the group receiving empagliflozin-metformin relative to the placebo group (P < 0.05). While insulin levels decreased in all active treatment groups, fasting blood sugar reduction was exclusive to the empagliflozin-metformin group. This group also demonstrated significant improvements in lipid profile (total cholesterol, triglycerides, low-density lipoprotein [LDL]) and hormonal parameters (testosterone, leptin, anti-Müllerian hormone) compared to both placebo and metformin monotherapy. Empagliflozin-metformin showed statistically significant superiority over linagliptin-metformin in reducing body weight (mean difference: -1.72 kg, 95% CI: -3.21 to -0.23; P = 0.019), triglycerides (mean difference: -3.35 mg/dL, 95% CI: -6.12 to -0.58; P = 0.013), anti-Müllerian hormone (mean difference: -0.62 ng/mL, 95% CI: -1.15 to -0.09; P = 0.018), and leptin levels (mean difference: -0.79 ng/mL, 95% CI: -1.45 to -0.13; P = 0.015). Conclusions: Combination therapy with empagliflozin-metformin demonstrates superior metabolic and hormonal benefits compared to metformin alone and linagliptin-metformin in infertile women with PCOS, suggesting its potential as a preferred treatment option before assisted reproductive technology. | en |
| DOI | https://doi.org/10.5812/gct-169067 | en |
| Keyword | Polycystic Ovary Syndrome | en |
| Keyword | Metformin | en |
| Keyword | Empagliflozin | en |
| Keyword | Linagliptin | en |
| Keyword | Infertility | en |
| Keyword | ICSI | en |
| Publisher | Brieflands | en |
| Title | Comparative Study of the Therapeutic Effects of Synoripa, Melijent-M, and Metformin on Anthropometric, Biochemical, and Hormonal Parameters in Women with Polycystic Ovary Syndrome Undergoing ICSI | en |
| Type | Research Article | en |
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