Pentoxifylline therapy after laparoscopic surgery for different stages of endometriosis: a prospective, double-blind, randomized, placebo-controlled study. Pentoxifylline versus placebo in the treatment of infertility associated with minimal or mild endometriosis: a pilot randomized clinical trial. Combined laparoscopic surgery and pentoxifylline therapy for treatment of endometriosis-associated infertility: a preliminary trial.
To evaluate the effects of pentoxifylline administration on patients with different stages of endometriosis on whom laparoscopy was performed.
                Prospective, double-blind, randomized, placebo-controlled clinical (Canadian Task Force classification I).
                University and private hospitals.
                Eighty-eight women, all with infertility, some with dysmenorrhea, dyspareunia, or pelvic pain, on whom a laparoscopic diagnosis of endometriosis was made.
                The treatment group received 800 mg pentoxifylline daily for 6 months immediately after surgery. The control group received placebo capsules. All patients were followed-up for 1 year thereafter.
                A comparison of pregnancy rate and recurrence of signs and symptoms in the 2 groups was performed. Forty-three patients were studied in the pentoxifylline group and 45 in the placebo group. The cumulative pregnancy rate was 39.5% and 35.6% in the treatment and control groups, respectively. The overall recurrence of signs and symptoms was 14% in the former group and 15.6% in the latter. There were no statistically significant differences between the 2 groups in rates of pregnancy and recurrence (p = .700 and .832, respectively). Nor was there any significant statistical difference between the same stages in the 2 groups regarding immunomodulation.
                According to the results of this study, and while keeping in mind that appropriate surgery is the main aspect of endometriosis treatment, there is no evidence that immunomodulation with pentoxifylline aids fertility or lessens recurrence of signs and symptoms in women with different stages of endometriosis (i.e., minimal, mild, moderate, or severe). The present study is the first prospective randomized controlled trial of the effect of pentoxifylline on future fertility in infertile women with asymptomatic minimal or mild endometriosis. After completion of a basic infertility workup and laparoscopy, patients were entered into the study and randomly allocated to receive either a 12 month course of oral pentoxifylline (800 mg/day) (n = 30) or an oral placebo (n = 30). Those patients with other infertility factors were included in the study only if the factors were correctable and ultimately determined to be non-contributory. Life-table analysis was used to compare pregnancy rates between the two groups over a 12 month period that started immediately after laparoscopy. The 12 month actuarial overall pregnancy rates were 31 and 18.5% in the pentoxifylline and placebo groups respectively. However, this difference was not statistically significant by the chi(2)-test. Similarly, the Cox regression method showed no differences between the hazard of pregnancy in the two groups studied (odds ratio, 0.56; 95% confidence interval, 0.18-1.67). Therefore, there is no evidence from this study that immunomodulation with pentoxifylline aids fertility in those women with minimal or mild endometriosis. Further studies including more infertile patients with endometriosis are desirable in order to confirm our results. Surgical treatment has modest efficacy for the treatment of infertility associated with early-stage endometriosis. Immunomodulation with pentoxifylline is considered as a new strategy potentially useful in treating endometriosis. Thus, this study investigated the usefulness of combined laparoscopic surgery and pentoxifylline therapy in the treatment of infertility associated with minimal to mild endometriosis.
                A prospective, randomized, controlled blind trial was conducted. Patients entered the study immediately after laparoscopic surgery and were randomly assigned to the treatment with either oral pentoxifylline (800 mg/day) (pentoxifylline group, n = 51) or an oral placebo (placebo group, n = 53). Patients were then observed for pregnancy for 6 months.
                Among 98 patients finally considered in the evaluation of the results, the 6 month overall pregnancy rates were 28 and 14% in the pentoxifylline and placebo groups, respectively. Thus, an absolute difference of 14% (95% CI -2 to 30) (Chi-squared test, P = 0.1) in the cumulative probability of pregnancy in 6 months after laparoscopic surgery in patients receiving pentoxifylline versus placebo post-operatively was observed.
                Our findings provide preliminary clinical evidence to suggest the new experimental treatment approaches, toward endometriosis, that are based on immunomodulation deserve further attention. Well-designed multicenter trials are warranted to confirm or refute our results.
This review has been updated in 2011. The results of the original review published in 2009 remain unchanged. There is still not enough evidence to support the use of pentoxifylline in the management of premenopausal women with endometriosis in terms of subfertility and relief of pain outcomes.