Progestin‐primed ovarian stimulation with or without clomiphene citrate supplementation in normal ovulatory women undergoing in vitro fertilization/intracytoplasmic sperm injection: A prospective randomized controlled trial

Summary Objective To compare the endocrinological profiles, cycle characteristics and pregnancy outcomes of progestin‐primed ovarian stimulation ( PPOS ) with or without clomiphene citrate ( CC ) supplementation in normal ovulatory women undergoing in vitro fertilization ( IVF )/intracytoplasmic sperm injection ( ICSI ). Design Prospective randomized controlled study. Patient(s) A total of 320 infertile women undergoing IVF / ICSI . Medroxyprogesterone acetate ( MPA ) and human menopausal gonadotropin ( hMG ) were simultaneously administered on menstrual cycle day 3. The women were randomized into 2 equal groups with or without CC supplementation. Measures The primary outcome measure was the percentage of women with profound pituitary suppression (luteinizing hormone [ LH ] <1.0 IU/L on the trigger day). The secondary outcomes were endocrinological profiles, cycle characteristics and pregnancy outcomes. Results The percentage of women with profound pituitary suppression was significantly lower in the study group ( hMG  +  MPA  +  CC ) than in the control group ( hMG  +  MPA ) (1.9% vs 33.1%, P  <   .001). The mean LH level during controlled ovarian stimulation ( COS ) was higher in the study group than in the control group ( P  < .001), but none of the patients in either group exhibited a premature LH surge. The doses of Gn in the study group were significantly lower than those in the control group (1334.06 ± 212.53 IU vs 1488.28 ± 325.08 IU, P  < .001). The number of oocytes retrieved was similar between the 2 groups (10.03 ± 5.97 vs 10.34 ± 7.52, P >  .05). No significant differences were observed in either the number of viable embryos or the pregnancy outcomes between the 2 groups. Conclusion(s) Clomiphene citrate is an effective adjuvant to alleviate pituitary suppression in the PPOS protocol; however, it has no impact on clinical outcomes.