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
| Autor: | Osamu Ishihara, Bjarke M. Klein, Joan-Carles Arce, Takeshi Kuramoto, Yoshimasa Yokota, Tetsunori Mukaida, Shoji Kokeguchi, Motoharu Ishikawa, Hirotsugu Oku, Naoki Hayashi, Noboru Inagaki, Akira Kuwahara, Toshihiro Fujiwara |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Adult Anti-Mullerian Hormone Male Ovulation endocrine system Pregnancy Rate medicine.medical_treatment Ovarian hyperstimulation syndrome Oocyte Retrieval Stimulation Fertilization in Vitro Hormone antagonist Intracytoplasmic sperm injection Andrology 03 medical and health sciences Young Adult 0302 clinical medicine Human fertilization Japan Ovulation Induction Pregnancy Medicine Humans Sperm Injections Intracytoplasmic 030219 obstetrics & reproductive medicine In vitro fertilisation Dose-Response Relationship Drug business.industry Obstetrics and Gynecology Fertility Agents Female medicine.disease Recombinant Proteins Pregnancy rate 030104 developmental biology Fertility Treatment Outcome Reproductive Medicine Infertility Female Follicle Stimulating Hormone Human business Biomarkers Hormone |
| Zdroj: | Fertility and sterility. 115(6) |
| ISSN: | 1556-5653 |
| Popis: | 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 antimullerian 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. |
| Databáze: | OpenAIRE |
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