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

ObjectiveTo 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). DesignProspective 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. MeasuresThe primary outcome measure was the percentage of women with profound pituitary suppression (luteinizing hormone [LH]<1.0IU/L on the trigger day). The secondary outcomes were endocrinological profiles, cycle characteristics and pregnancy outcomes. ResultsThe 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 (1334.06212.53IU vs 1488.28 +/- 325.08IU, 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.