Stair-step protocol vs. traditional protocol in polycystic ovary syndrome women using clomiphene citrate

Chronic anovulation is one of the most common causes of infertility in women with polycystic ovary syndrome (PCOS) and there are several treatments for it. The present study was performed aimed to determine the efficacy of the stair-step protocol (SSP) using clomiphene citrate (CC) in patients with polycystic ovary syndrome and compare it with the traditional regimen.

This double-blind randomized clinical trial study was performed on 60 patients with PCOS in Sanandaj Besat Hospital in 2018-2019. Patients were randomly divided into control (traditional) and study (stair-step) groups. In the stair-step group, the patient received 50 mg of CC daily for 5 days from the fifth day of the cycle, and if there was no response, the dose was doubled, and failure to respond led to the use of 150 mg. In the control group, the process of CC administration in each cycle was for 5 days with the prescribed doses. The effect of CC administration was determined by ultrasonography one week after the end of the drug. Finally, the variables of egg size, ovulation interval, pregnancy rate, and CC side effects were compared in the two groups using SPSS software (version 18), Kolmogorov-Smirnov test, and t-test. P<0.05 was considered statistically significant.

The ovulation period was significantly shorter in the SSP than in the control group (21.40±0.98 vs. 51.86±5.94 days). Ovulation rate (17.72±2.40 vs. 19.03±4.40) and pregnancy rate (0.87±0.12 vs. 0.93±0.10) were not significantly different between the case and control groups. Moreover, no significant difference was found between the groups regarding the side effects of CC and endometrial thickness (p>0.05).

SSP has a very short treatment period with no adverse effects on ovulation and pregnancy. It also has no side effects in patients with PCOS.