Randomized, assessor-blind, antimüllerian hormone–stratified, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta
We reported the impact of follitropin delta dose and ovarian reserve on ovarian response established in Japanese in vitro fertilization/ intracytoplasmic sperm injection patients.
Published
VOLUME 115, ISSUE 6, P1478-1486
Authors:
Osamu Ishihara, M.D., Ph.D., Bjarke M. Klein, Ph.D., Joan-Carles Arce, M.D., Ph.D. for the Japanese Follitropin Delta Phase 2 Trial Group
Abstract:
Objective
To establish the relationship between follitropin delta doses (recombinant follicle-stimulating hormone produced from the human cell line PER.C6) and ovarian response in Japanese women undergoing in vitro fertilization/intracytoplasmic sperm injection treatment and to evaluate the influence of initial antimüllerian hormone (AMH) levels.
Design
Randomized, controlled, assessor-blind, AMH-stratified (low 5.0–14.9 pmol/L; high 15.0–44.9 pmol/L) dose-response trial.
Setting
Reproductive medicine clinics.
Patient(s)
A total of 158 Japanese women (20–39 years of age).
Intervention(s)
Controlled ovarian stimulation with 6, 9, or 12 μg/d of follitropin delta or 150 IU/d follitropin beta as a reference arm in a gonadotropin-releasing hormone antagonist cycle.
Main Outcome Measure(s)
Number of oocytes retrieved.
Result(s)
Among all women who started stimulation, the mean number (± standard deviation) of oocytes retrieved in the 6 μg/d, 9 μg/d, and 12 μg/d follitropin delta groups was 7.0 ± 4.1, 9.1 ± 5.6, and 11.6 ± 5.6, respectively, and a significant dose-relation was established, which also remained significant within each AMH strata. Significant dose-responses also were observed for serum estradiol, inhibin A, and progesterone at end-of-stimulation with follitropin delta. The vital pregnancy rate per started cycle with follitropin delta was 19% for 6 μg/d, 20% for 9 μg/d, and 25% for 12 μg/d. The rate of early moderate/severe ovarian hyperstimulation syndrome with follitropin delta was 8% for 6 μg/d, 8% for 9 μg/d, and 13% for 12 μg/d, with 82% of the cases in the high AMH stratum.
Conclusion(s)
This trial establishes the dose-response relationship between follitropin delta and ovarian response in Japanese women.
Clinical Trial Registration Number
NCT02309671.
