Clomiphene Stair-Step Protocol versus Traditional Protocol for Ovulation Induction in Polycystic Ovarian Syndrome Patients

Background: Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder among women in the reproductive period. It is one of the leading causes of infertility. The manifestations of PCOS include irregular or no menstrual periods, excess body weight and facial hair, acne, heavy periods and pelvic pain. The aim of this study is to determine the efficacy of stair step protocol compared to traditional protocol in ovulation induction of polycystic ovarian syndrome (PCOS) patients in terms of increasing rate of ovulation and pregnancy.

Methods: This study is non-blinded, multicenter, randomized controlled study and was carried out on infertile women attending the Fertility Clinic of Tanta University Hospital and Hurghada General Hospital. Two Hundred infertile patients with PCOS criteria and no other causes of infertility were enrolled according to inclusion and exclusion criteria.

Results: Student t test was used for the continuous variables (FSH, LH, Prolactin, AMH, TSH, Free testosterone). Student t test was used for the continuous variables (Endometrial thickness, Time to ovulate (d)). Chi-square analysis was used for the categorical variables (Ovulation rate, Pregnancy rate). Chi-square analysis was used for the categorical variables (Ovulation rate per cycle). There was no significant difference between two groups as regards mild and severe side effects.

Conclusions: This study concluded that stair step regimen improves the ovulation rate and pregnancy rate without any detrimental side effects compared to traditional regimen. It helps to know the sensitivity and resistance of an individual to clomiphene citrate much earlier and helps to plan ahead with alternative treatment for desired outcome. The advantage of shorter treatment period with similar side effects makes the stair step protocol suitable for use in routine clinical practice.