A prospective, open, randomized clinical study to assess the efficacy and safety of two gonadotropin preparations administered in WHO Group II anovulatory subfertile women

Abstract

Objective: To assess the efficacy and safety of 2 gonadotropin preparations in inducing ovulation in clomiphene-resistant WHO Group II anovulatory subfertile women. Methods: Twenty patients were randomized to receive either Metrodin intramuscularly or Metrodin HP subcutaneously and underwent 45 treatment cycles. A maximum of 3 cycles were offered unless conception or severe adverse reaction occurred. The presence of redness, swelling, bruising and pain of the injection sites was noted and compared. Results: Seven patients became pregnant (3 in the Metrodin group and 4 in the Metrodin HP group) and the pregnancy rates per patient and per cycle were 7/20 (35%) and 7/45 (15.6%), respectively. No local reactions were found in the majority of cycles. There was no significant difference in pregnancy rates and the number of cycles complicated by bruise, pain, itching, redness or swelling between these 2 groups. Conclusions: This clinical study shows that in WHO Group II anovulatory patients Metrodin HP administered subcutaneously by self-injection is as safe and effective as Metrodin administered intramuscularly in inducing ovulation.