Laparoscopy and the Era of ART in Unexplained Primary Infertility: Randomized Clinical Trial

OBJECTIVES: To compare the outcomes (effectiveness and safety) of laparoscopic surgery as a treatment option of unexplained primary infertil-ity with ART. DESIGN: Randomized prospective clinical trial. PATIENTS AND METHODS: 536 patients with primary unexplained infertility diag-nosed by normal hormonal profile and ovulatory at ovulation testing, nor-mal HSG, and normal semen analysis were randomized according to com-puter based system into: group I, 267 patients were managed with laparos-copy with aim of diagnosis and treatment. While in group II, 269 patients were treated by controlled ovarian stimulation and IUI up to 3 trials, if failed ICSI was performed. We calculated cumulative pregnancy outcome after two years for each group. RESULTS: In group I, Laparoscopic find-ings were as follow: minimal to mild endometriosis was found in 83 cases (31.1%), moderate to severe endometriosis 44 cases (16.5%) managed by adhesiolysis and ablation-excision of endometriotic implants. The preg-nancy rate after two years was 55.4% (46 cases), 38.6% (17 cases) in both respectively, significant periadnexal and pelvic adhesions 41 cases (15.3%) managed by adhesiolysis with pregnancy occurred in 22 cases (53.7%), while laparoscopy revealed hypo plastic tubes 33 cases (12.4%), and 66 cases (24.6%) remained unexplained. With the expectant manage-ment, pregnancy rate was 21.2% (7 cases), and 15.2% (10 cases) respec-tively. The overall pregnancy rate in group I is 102 cases (38.2%). In group II, 114 cases (42.3) got pregnant as 27 cases (8.78%) by IUI, and 87 cases (33.52%) by ICSI. OHSS occurred in 3 cases, multiple pregnancy occurred in 13 cases, abortion and miscarriage 6 cases in group II, while 2 cases of ectopic pregnancy in group I, and the patients of both groups did not suffer any significant operative complications. CONCLUSION: Laparoscopy is safe and effective as a treatment option in unexplained infertility and its performance provides diagnostic findings which are valuable in manage-ment of the unidentified causes, enabling good number of patients to have pregnancy spontaneously which is comparable to ART while avoiding economic, psychological and physical burdens of ART, like OHSS, multi-ple pregnancy and abortion which are higher in cases treated with ART. In the future if ART is needed, the success rate is increased by closure of (undiagnosed) hydrosalpinx and reposition of the ovary to facilitate oocyte retrieval.