Is clomiphene citrate stair-step protocol a good alternative to gonadotrophins in clomiphene-resistant PCO patients? Prospective study.

Aim: To compare the efficacy and safety of the clomiphene citrate (CC) stair-step protocol with standard gonadotrophin (follicle-stimulating hormone) treatment in clomiphene-resistant polycystic ovary syndrome (PCOS) patients. The study was a prospective cohort study in a tertiary infertility center in Abu Dhabi, United Arab Emirates (UAE).

Methods: The subjects consisted of 100 PCOS CC-resistant patients who attended between January 2014 and January 2015. Fifty received CC again but in accordance with the stair-step protocol, and the other 50 received the standard gonadotrophin treatment used in the center in which the study was conducted. The primary outcome measure was dominant follicle achievement; the secondary outcome measures were (i) clinical pregnancy rate; (ii) time to ovulation measured from treatment initiation to sonographic confirmation of a dominant follicle in days; and (iii) adverse effect occurrence.

Results: There was no difference between the two treatment modalities concerning the ability to achieve a dominant follicle or the clinical pregnancy rate. The time to ovulation was significantly shorter with the CC stair-step protocol than with gonadotrophin treatment. Ovarian hyperstimulation syndrome and ovarian cyst formation were more likely to occur with gonadotrophin treatment.

Conclusion: Clomiphene citrate stair-step protocol can be offered to PCOS CC-resistant patients as an alternative to gonadotrophin therapy with similar efficacy.