Follitropin delta in IVF/ICSI programs


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

Objective: To evaluate the efficacy of follitropin delta versus follitropin alfa used in IVF programs in terms of the number of obtained oocytes, metaphase II (MII) oocytes, the rate of fertilization, high-quality blastocyst yield, the proportion of euploid embryos, as evidenced by preimplantation genetic testing for aneuploidy (PGT-A), and pregnancy rate. To evaluate the safety, usability, and patient compliance to the application of follitropin delta. Materials and methods: The investigation included 35 patients undergoing IVF treatment at 22 to 36 years of age. Controlled ovarian hyperstimulation (OHS) was done using the individualized doses of follitropin delta. The daily dose of the drug was 5 to 12 ig in accordance with its instructions. The follitropin alfa group consisted of 35 patients aged 21 to 36 years. The starting daily dose of the drug was 100 to 225IU. Results: Among the patients who underwent ovarian stimulation with follitropin delta, (42.8%) (15/35) of cases were observed to have a normal ovarian response (10-19 oocytes), none of the patients had a poor response (1-3 oocytes), 28.6% (10/35) of cases had a suboptimal response (4-9 oocytes), and 28.6% (10/35) had a hyperergic response (20 or more oocytes). In the follitropin alpha group, there was a normal ovarian response (10-19 oocytes) in 51.4% (18/35) of cases, poor and suboptimal responses (1-3 and 4-9 oocytes, respectively) in 17.1% (6/35) and 22.9% (8/35) of patients, respectively, and a hyperergic response (20 or more oocytes) in 8.6% (3/35) of cases. In the follitropin delta group, the mean number of oocytes retrieved was 15.4; of them, MII oocytes were 76% (11.7/15.4). In the follitropin alfa group, there was an average of10.9 obtained oocytes; of them MII oocytes were 74% (8.1/10.9). The fertilization rate was 76.9% (9.0/11.7) in the follitropin delta group and 80.2% (6.5/8.1) in the follitropin alfa group. At the same time, the high-quality embryos among the MII oocytes were 43.6% (5.1/11.7) and 47% (3.8/8.1) in the follitropin delta and follitropin alpha groups, respectively. The pregnancy rate after embryo transfer in the cycle with follitropin delta and follitropin alfa was 43.8% (7/16) and 40.9% (9/22), respectively. The risk of OHS syndrome (OHSS) was noted in 14.3% (5/35) of patients in the follitropin delta group and 11.4% (4/35) in the follitropin alfa group. Mild OHSS was observed in all cases. Conclusion: The individualized gonadotropin dose in IVF programs based on initial patient characteristics (body weight and AMH level) ensures an adequate ovarian response, by maintaining a high stimulation efficiency and pregnancy rate. At the same time, it is noteworthy that, when using follitropin delta, there was no poor response to OHS, but there was a low suboptimal response rate. In addition, the starting follitropin alfa dose required upward correction in 11.4% (4/35) of cases. Both examined group showed a comparable risk of OHSS.

Full Text

Restricted Access

About the authors

Ksenia V. Krasnopolskaya

Moscow Regional Research Institute of Obstetrics and Gynecology; PRIOR CLINIC Reproductive Health Clinic

Email: guzmoniiag@gmail.com
Corresponding Member of the RAS, Dr. Med. Sci., Professor, Head of the Department of Reproductology

Kamila M. Isakova

Moscow Regional Research Institute of Obstetrics and Gynecology

Email: isa-kama@yandex.ru
PhD, obstetrician-gynecologist, Researcher

Irina Yu. Ershova

Moscow Regional Research Institute of Obstetrics and Gynecology; PRIOR CLINIC Reproductive Health Clinic

Email: i3236987@gmail.com
PhD, Researcher at the Department of Reproduction

Lidiya V. Shostenko

Moscow Regional Research Institute of Obstetrics and Gynecology

Email: lidsonnn@gmail.com
obstetrician-gynecologist, postgraduate student of the Department of Reproduction

Anna V. Shishkina

Moscow Regional Research Institute of Obstetrics and Gynecology

Email: anya.shostenko@yahoo.com
obstetrician-gynecologist, postgraduate student of the Department of Reproduction

References

  1. Von Wolff M. The role of natural cycle IVF in assisted reproduction. Best Pract. Res. Clin. Endocrinol. Metab. 2019; 33(1): 35-45. https://dx.doi.org/10.1016/j.beem.2018.10.005.
  2. Чеботникова Т.В. Гонадотропины: история создания. Вестник репродуктивного здоровья. 2008; 1-2: 78-9. https://dx.doi.org/10.14341/brh20081-278-79.
  3. Бекетова А.Н., Краснопольская К.В., Назаренко Т.А., Кабанова Д.И. Мочевые и рекомбинантные гонадотропины в программах ЭКО (обзор литературы). Проблемы репродукции. 2014; 3: 45 52.
  4. Olsson H., Sandstrom R., Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non human cell line. J. Clin. Pharmacol. 2014; 54(11): 1299-307. https://dx.doi.org/10.1002/jcph.328.
  5. Koechling W., Plaksin D., Croston G.E., Jeppesen J.V., Macklon K.T., Andersen C.Y. Comparative pharmacology of a new recombinant FSH expressed by a human cell line. Endocr. Connect. 2017; 6(5): 297-305. https://dx.doi.org/10.1530/EC-17-0067.
  6. Bissonnette F., Minano Masip J., Kadoch I.J., Librach C., Sampalis J., Yuzpe A. Individualized ovarian stimulation for in vitro fertilization: a multicenter, open label, exploratory study with a mixed protocol of follitropin delta and highly purified human menopausal gonadotropin. Fertil. Steril. 2021; 115(4): 991-1000. https://dx.doi.org/10.1016/j.fertnstert.2020.09.158.
  7. Arce J.C., Larsson P., Garcia-Velasco J.A. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod. Biomed. Online. 2020; 41(4): 616-22. https://dx.doi.org/10.1016/j.rbmo.2020.07.006.
  8. Nyboe Andersen A., Nelson S.M., Fauser B.C., Garcia-Velasco J.A., Klein B.M., Arce J.C.; ESTHER-1 study group. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil. Steril. 2017; 107(2): 387-96. e4. https://dx.doi.org/10.1016/j.fertnstert.2016.10.033.
  9. Ishihara O., Arce J.C.; Japanese Follitropin Delta Phase 3 Trial (STORK) Group. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod. Biomed. Online. 2021; 42(5): 909-18. https://dx.doi.org/10.1016/j.rbmo.2021.01.023.
  10. La Marca A., Sunkara S.K. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum. Reprod. Update. 2014; 20(1): 124-40. https://dx.doi.org/10.1093/humupd/dmt037.
  11. Broer S.L., Broekmans F.J., Laven J.S., Fauser B.C. Anti-Mullerian hormone: ovarian reserve testing and its potential clinical implications. Hum. Reprod. Update. 2014; 20(5): 688-701. https://dx.doi.org/10.1093/humupd/dmu020.
  12. Zeng R., Chen H., Zeng X., Qin L. The essential role of body weight in adjusting Gn dosage to prevent high ovarian response for women with PCOS during IVF: a retrospective study. Front. Endocrinol. (Lausanne). 2022; 13: 922044. https://dx.doi.org/10.3389/fendo.2022.922044.
  13. Qiao J., Zhang Y., Liang X., Ho T., Huang H.Y., Kim S.H. et al. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum. Reprod. 2021; 36(9): 2452-62. https://dx.doi.org/10.1093/humrep/deab155.
  14. Ishihara O., Klein B.M., Arce J.C.; Japanese Follitropin Delta Phase 2 Trial Group. Randomized, assessor-blind, antimullerian hormone-stratified, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta. Fertil. Steril. 2021; 115(6): 1478-86. https://dx.doi.org/10.1016/j.fertnstert.2020.10.059.
  15. Fernandez-Sanchez M., Visnova H., Yuzpe A., Klein B.M., Mannaerts B., Arce J.C.; ESTHER-1 and ESTHER-2 Study Group. Individualization of the starting dose of follitropin delta reduces the overall OHSS risk and/or the need for additional preventive interventions: cumulative data over three stimulation cycles. Reprod. Biomed. Online. 2019; 38(4): 528-37. https://dx.doi.org/10.1016/j.rbmo.2018.12.032.
  16. Yacoub S., Cadesky K., Casper R.F. Low risk of OHSS with follitropin delta use in women with different polycystic ovary syndrome phenotypes: a retrospective case series. J. Ovarian Res. 2021; 14(1): 31. https://dx.doi.org/10.1186/s13048-021-00773-5.

Supplementary files

Supplementary Files
Action
1. JATS XML

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies