New insights into pentoxifylline and α-lipoic acid: Co-administration with clomiphene citrate for ovulation induction in anovulatory women with polycystic ovary syndrome.

Abstract

Objective: This study investigated the effects of pentoxifylline (PTX) and α-lipoic acid (ALA) on ovulation and pregnancy rates in women with clomiphene citrate (CC) resistant polycystic ovary syndrome (PCOS).

Methods: A prospective, randomized, controlled, open-label study was conducted on women with CC-resistant PCOS. In total, 120 PCOS patients were randomly assigned to four groups of 30 patients each, as follows: group 1 was the control group; group 2 received 400 mg of PTX twice daily; group 3 received 600 mg of ALA twice daily; and group 4 received a combination of PTX and ALA, following the same regimen as the previous groups. All groups were administered 150 mg of CC, the standard therapy for ovulation induction (ClinicalTrials.gov: NCT05231980).

Results: The cumulative ovulation rate was highest in the combined PTX-ALA group at 77% (23 cases), followed by the PTX group at 70% (n=21), the ALA group at 40% (n=12), and the control group at 30% (n=9) (p=0.0003). The cumulative pregnancy rates were 40% (n=12), 37% (n=11), 10% (n=3), and 3% (n=1) for the PTX-ALA, PTX, ALA, and control groups, respectively (p=0.0005). Endometrial thickness (ET) was significantly greater in the PTX group than in the control group.

Conclusion: Co-administration of PTX with CC significantly improved the ovulation rate, pregnancy rate, ET, and ovarian response to stimulation in patients with anovulatory PCOS. This combination may provide an effective, affordable, and safe treatment protocol for women with CC-resistant PCOS.