Background: To analyze the therapeutic results of one dose of 3 million IU of recombinant interleukin-2 (rIL-2) left intracyst (group I) versus two doses with a 1-month interval (group II) after transvaginal ultrasound (US)-guided drainage of endometriomas under the effect of GnRH analogues. Methods: Prospective and randomized clinical trial (helped by a random number table) at a University Hospital. Twenty-four consecutive patients with endometriomas initially sent to us for laparotomy and conservative surgery for endometriosis were included. Interventions: Treatment with GnRH analogues every 28 days, 3 doses. Under their effect, one or two transvaginal US-guided punctures were performed in order to aspirate the endometriomas, and 3 million IU of rIL-2 were left in the aspirated cysts each time. Main outcome measures: Clinical results: two menstruations after GnRH analogues. Other secondary outcome measures were: the time until recurrence of cysts, symptoms and CA-125 >35 U/ml, and the need for further medical or surgical treatment. Results: They were moderate or good in >50% of cases with one drainage and one dose of 3 million IU of rIL-2 intracyst, but were better with a second drainage and two doses of rIL-2 (25 vs. 58.3% ‘good results’). There were fewer recurrences and the interval before recurrence was longer after two doses but differences were not significant. Six patients from group I (50%) and 3 from group II (25%) needed laparotomy and conservative surgery at 17.5 ± 8.7 months (total time of follow-up = 33 ± 8.8 months). Conclusions: Treatment of endometriomas with transvaginal US-guided drainage and rIL-2 left in the cysts under endometrial suppressive therapy with GnRH analogues has beneficial effects, improving clinical manifestationsand avoiding some surgical therapies. The use of a higher dose of rIL-2 does not produce better results, whereas drainage + rIL-2 twice does.

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