Objective: To evaluate endocrine characteristics and clinical outcomes in normal ovulatory patients undergoing controlled ovarian hyperstimulation (COH) with the use of a Duphaston and hMG protocol during in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) treatments in combination with frozen-thawed embryo transfer (FET) compared with the characteristics and outcomes of patients undergoing an Utrogestan and hMG protocol.

Design: Prospective controlled study.

Setting: Tertiary care academic medical center.

Patient(s): A total of 250 infertile patients undergoing IVF/ICSI treatments.

Intervention(s): Duphaston (20 mg/d) or Utrogestan (100 mg/d) was taken orally from cycle day 3 until the trigger day, with hMG (150-225 IU) administered when appropriate. When the dominant follicles reached maturity, 0.1 mg GnRH agonist was used as the trigger. Viable embryos were cryopreserved in both protocols for transfer at a later time.

Main outcome measure(s): The primary outcome was the number of oocytes retrieved. Secondary outcomes included the incidence of premature LH surge, the number of viable embryos, and clinical pregnancy outcomes from FET cycles.

Result(s): Consistent LH suppression was achieved during COH. None of the participants experienced a premature LH surge. The number of oocytes retrieved (8.22 ± 5.46 vs. 8.8 ± 5.62) was similar between the two groups. No between-group significant differences were observed in the number of mature oocytes (7.2 ± 4.72 vs. 6.98 ± 4.68), fertilized oocytes (6.16 ± 4.34 vs. 6.32 ± 4.23), and viable embryos (2.96 ± 2.22 vs. 3.4 ± 2.54). Furthermore, the clinical pregnancy rates (53.04% vs. 51.7%), early miscarriage rates (8.2% vs. 11.84%), implantation rates (38.68% vs. 35.71%), and cumulative pregnancy rates per woman (66.67% vs. 69.47%) were also similar.

Conclusion(s): Duphaston administration during COH was similar to Utrogestan in the prevention of LH surge, embryonic characteristics, and pregnancy outcomes.

Clinical trial registration number: ChiCTR-IOR-15007265.