Clomiphene citrate ‘stair-step’ protocol vs. traditional protocol in patients with polycystic ovary syndrome: a randomized controlled trial

Abstract

The stair-step protocol was determined to have a significantly shorter treatment period without any detrimental effect on the ovulation and pregnancy rates.

Ovulation induction using clomiphene citrate using stair – Step regimen versus traditional regimen in polycystic ovary syndrome women – A randomized control trial

“…Similarly, Deveci et al . [ 5 ] after performing similar study reported his results with an ovulation rate of 43.3% in the study group and 33.3% in the control group.…”

Randomized Trial Comparing the Effect of Endometrial Shedding With Medroxyprogesterone Acetate With Random Start of Clomiphene Citrate for Ovulation Induction in Oligo-ovulatory and Anovulatory Women

“…Deveci et al similarly found no difference in endometrial thickness between these two treatment protocols in their study of women using up to two cycles of CC. 21 Our study differs from that of Deveci et al 21 in that we randomly assigned patients before their first dose of CC. In contrast, the retrospective study by Budinetz et al showed that endometrial thickness was significantly less in the stair-step cycle than in the subsequent CC cycle, in which the dose of CC was increased if no response was seen by day 14, 20 much earlier than the reassignment day in our study (day 21).…”

“…19 Furthermore, the time to ovulation was 23 to 35 days with the stair-step protocol compared with 55 to 88 days with the traditional protocol. 19 Only one study has had sufficient statistical power to detect a difference between pregnancy rates in women undergoing a stair-step protocol and women undergoing a traditional protocol after a maximum of two cycles of CC with a maximum daily dose of 100 mg. 21 In that study, the pregnancy rates between groups were similar: 16.7% in the stair-step approach and 10% in the traditional protocol, but the duration of treatment was 28.1 days shorter in the stair-step approach. 21 Although our study appeared to show a faster time to ovulation (15 days) in women using the stair-step protocol compared with a traditional protocol, the difference was not statistically significant.…”

“…24 Recently, the stair-step approach to prescribing CC for ovulation induction, without induction of withdrawal bleeding, has gained popularity; however, studies comparing the two approaches are limited. 19,21 A retrospective study of multiple cycles of CC showed that the conception rate per ovulatory cycle was 27.7% in women who did not take MPA before CC compared with 6.6% in those who took MPA; the corresponding live birth rates were 19.7% and 5.4%, respectively. 17 In a prospective trial, Hurst et al demonstrated a higher ovulation rate using CC 100 mg daily in the stair-step protocol (64%) compared with the traditional protocol (22%).…”

“…17,22 To date, only one prospective study has compared the endometrial effects of having a progestogen-induced withdrawal bleed before CC with not having such a bleed. 21 We designed this study to assess differences in endometrial thickness between women having an MPA-induced withdrawal bleed and women not receiving any pre-treatment before taking CC for ovulation induction. We also sought to determine the feasibility of instituting a larger RCT with statistical power to find differences in pregnancy rates between the groups.…”