A prospective randomized open study comparing goserelin (Zoladex) plus surgery and surgery alone in the management of ovarian endometriomas

Objective To determine whether goserelin (Zoladex(TM); AstraZeneca, London, UK), plus surgery offers advantages over surgery alone in the management o f ovarian endometriomas. Design Prospective, multicentre, randomized, open-label, parallel-group stu dy. Interventions Following preoperative aspiration of endometriomas, they were sized by ultrasound, a diagnosis of endometriosis confirmed by laparoscopy and its severity assessed. Patients were stratified according to endometri oma size and randomly allocated to one of two groups: group 1 (G1; n = 21) received a monthly (every 28 days) subcutaneous injection of goserelin 3.6 mg for 3 months (12 weeks); group 2 (G2; n = 27) received no treatment. At 3 months, the size of endometriomas was reassessed in both groups before de finitive excision. Both groups were reassessed at 6 months postsurgery. Main outcome measures Change in size of the largest endometrioma from entry to just prior to excision. Results The mean change in endometrioma size was -2.29 cm in G1 and -1.29 c m in G2. The resulting (adjusted) mean difference of -1.25 cm was statistic ally significant in favour of G1 (P = 0.036, 95% CI -2.42 to -0.08 cm). Ver y difficult surgery was reported in four (22%) patients in G1 and 10 (46%) patients in G2. Mean duration of surgery was 74.2 min in G1 and 86.4 min in G2. There was a trend towards a greater reduction in mean Additive Diamete r of Implants (ADI) score at 6 months postsurgery in G1 compared with G2 (- 65.9 vs. -56.6). Both groups were comparable in terms of the number of comp lete excisions of their endometrial cysts at surgery, blood loss at surgery , Revised American Fertility Society (R-AFS) scores and pelvic symptoms. Go serelin was well tolerated. Conclusions Laparoscopic aspiration of endometriomas followed by a monthly goserelin 3.6 mg depot for 3 months compared with laparoscopic aspiration a lone results in significantly smaller endometriomas at 3 months and a trend towards a greater reduction in ADI score.