OBJECTIVE: To compare the clinical efficacy of raloxifene and clomiphene in the treatment of polycystic ovary syndrome (PCOS) complicated with infertility. METHODS: In retrospective study, clinical information of 137 PCOS patients with infertility in our hospital during Jun. 2012-Feb. 2015 were selected and divided into raloxifene group (70 cases) and clomiphene group (67 cases) according to therapy plan. Raloxifene group received Raloxifene tablet 120 mg at the fifth day of menstrual cycle, qd, for consecutive 5 d. Clomiphene group received Clomiphene citrate capsule 100 mg at the fifth day of menstrual cycle, qd, for consecutive 5 d. Both groups received B-ultrasound to detect the follicular diameter and endometrial development at the twelfth day of menstrual cycle. When endometrial thickness was ≥7 mm and the diameter of one follicle was ≥18 mm at least, all patients received abdominal subcutaneous injection of Triptorelin acetate injection 0.1 mg to induce ovulation; after 48 h, ovulation was confirmed by B ultrasound. The patients with insufficient luteal function should take dydrogesterone 10 mg as appropriate,q12 h, till 15 d after ovulation. The endometrial thickness, the number of follicles with diameter≥18 mm and follicular maturation time were compared between 2 groups on the day of injection. The sex hormone levels before treatment and on the day of injection, as well as ovulation, outcome indexes and the occurrence of ADR in 2 groups were compared. RESULTS: The endometrial thickness of raloxifene group was greater than that of clomiphene group; the number of follicles with diameter ≥18 mm was more than clomiphene group; the follicular maturation time was shorter than clomiphene group, with statistical significance (P<0.05). Before treatment, there was no statistical significance in serum levels of P, E2, FSH and LH between 2 groups (P>0.05). Compared to before treatment, there was no statistical significance in serum levels of P, E2, FSH or LH in 2 groups on the day of injection (P>0.05). Serum levels of LH in 2 groups were decreased significantly, and serum level of LH in raloxifene group was significantly lower than in clomiphene group, with statistical significance (P<0.05). The ovulation rate of raloxifene group was significantly higher than clomiphene group, with statistical significance (P<0.05); while the pregnancy rate, abortion rate, continuous pregnancy rate of 2 groups had no statistical significance (P>0.05). There was no statistical significance in the total incidence of ADR (5.71% vs. 8.96%) between 2 groups (P>0.05). CONCLUSIONS: Raloxifene has better ovulation induction effect than clomiphene, and it can improve the sex hormone levels of PCOS patients with infertility, with few ADR, and similarity in long-term clinical effect with clomiphene.
The Department of Obstetrics and gynecology,The First Affiliated Hospital of Chongqing Medical University,Chongqing Key Laboratory of Maternal and Fetal Medicine,Joint International Research Laboratory of Reproduction and Development of Chinese Ministry of Education,Chongqing Medical University