Authors: Mohamed Salama, Haitham Hamza
Objective: This prospective randomized study aimed to study whether pretreatment with drosperinone containing COC before letrozole induction of ovulation could improve the response in clomiphene (CC)-resistant women with polycystic ovarian syndrome (PCOS).
Methods: The study comprised a total of 125 infertile women (227 cycles) with CC resistant PCOS selected from the clinics affiliated to the Department of Obstetrics and Gynecology of Menoufia University - Egypt. Patients were randomized to either group (A) (61 patients, 116 cycles), patients received drospirenone-containing oral contraceptive pills (OCP) for 42 days then letrozole 2.5 mg twice daily starting from the 2nd day of menstruation for 5 days and group (B) patients received letrozole in the same manner but without OCP pretreatment (64 patients, 111 cycles). 10000 IU hCG administered when mature follicles reached ≥ 18 mm in diameter. Data obtained were statistically analyzed using SPSS software version 20 for Windows. Unpaired t-test used to compare means between both groups while paired t-test used to compare means in group A before and after COC pretreatment, proportions were analyzed using the χ2 test, correlations were analyzed with Pearson correlation and logistic regression and ROC curve used for analysis of the predictors for pregnancy in group (A). A P value of less than .05 was considered statistically significant.
Trial ID: PACTR201611001569368.
Results: Ovulation was significantly higher in Group (A) than in group (B) 98/116 cycles (84.5%) and 74/111 cycle (66.7 %), p=0.003, clinical pregnancy rate was significantly higher in Group (A) than in group (B)32/116 cycles (27.6%) and 16/111 cycle (14.4%), p=0.02. Statistically significant decrease in LH (14.9 ± 3.96 vs 6.8 ± 2.6), Testosterone (2.2 ± 0.72 vs 1.2 ± 0.68) and FAI (8.9 ± 2.3 vs 4.1 ± 1.8) and DHEAS (254.0 ± 92.49 vs 165.8 ± 48.79) and increase in SHBG (25.4 ± 13.67 vs 56.5 ± 12.95) and ovarian stromal pulsatility index “OSPI” (0.9 ± 0.07vs 1.06 ± 0.06) were observed in group (A) before and after pretreatment with COC (p value < 0.001). There were no significant changes in BMI, FSH, fasting insulin and glucose and HOMA-IR. After OCP pretreatment, the mean change in LH correlated positively with the mean change in testosterone and free androgen index “FAI” (p=0.006 and 0.013 respectively) and the mean change in ovarian stromal pulsatility index (OSPI) correlated negatively with LH, testosterone and FAI (p=0.02, 0.007 and 0.013 respectively). The best predictors for pregnancy in group (A) were change in LH, testosterone and FAI at cutoff points (≤ -7.72 mIU/ml, ≤ -1.04 nmol/ml and ≤ -5.02respectively) with sensitivity /specificity (91.2/74.07, 82.4/88.9 and 79.4/85.2 respectively).
Conclusion: Pretreatment with drospirenone-containing COC before letrozole ovulation induction in patients with CC-resistant PCOS can improve ovulation and pregnancy rates.
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