Review of the results of clinical studies of follitropin delta in ovarian stimulation protocols. The first experience of its use in Russia
The paper presents the results of the clinical studies ESTHER-1, ESTHER-2, MARCS, STORK, and GRAPE, which have evaluated the efficacy of follitropin delta for ovarian stimulation (OS) in infertility programs with assisted reproductive technologies (ART). The ESTHER-1 and ESTHER-2 studies have been conducted on 1,326 women from several countries around the world. The studies have evaluated the effectiveness of individual calculation of the dosage of the OS drug, as well as its safety profile, especially in terms of the development of ovarian hyperstimulation syndrome (OHSS), one of the most common and serious complications of controlled OS. The ESTHER-2 study has assessed the safety profile of the second and third OS cycles. The STORK and GRAPE studies of 347 patients from Japan and 1009 women from several Asian countries have evaluated the efficacy of follitropin delta, taking into account the ethnic characteristics of the patients. The MARCS study enrolling 110 patients has analyzed the efficacy of a mixed protocol of follitropin delta and a highly purified urine-derived menopausal gonadotropin. The conducted clinical studies have shown that individual calculation of the dosage of follitropin delta offers benefits in a significant reduction in the risks of OHSS with comparable or better indicators for the number of oocytes collected, in the frequency of pregnancy, etc., which also allow the use of smaller total follitropin delta doses than those in the standard regimens. Following a review of the studies examples of clinical experience with follitropin delta in mono- and mixed protocols for women with low, normal, and high ovarian reserves are given.Kalugina A.A., Boyarsky K.Yu., Makolkin A.A., Zvereva I.O., Voznesenskaya Yu.V., Kholodov D.V.
Conclusion: The gained experience with follitropin delta confirms its efficacy in both mono- and mixed protocols in patients with low, normal and high ovarian reserves. Follitropin delta helps achieve a predictable ovarian response while minimizing the risk of OHSS, including patients with endocrine factor infertility (including polycystic ovary syndrome).
Keywords
infertility
ART
ovarian hyperstimulation syndrome
gonadotropins
follitropin delta
References
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Received 14.10.2021
Accepted 21.10.2021
About the Authors
Alla S. Kalugina, reproductologist, Dr. Med. Sci., Professor of the Department of Obstetrics, Gynecology and Neonatology, Academician I.P. PavlovFirst St. Petersburg State Medical University, Ministry of Health of the Russian Federation; Skanfert Clinic, St. Petersburg, Alla19021962@gmail.com,
191186, Russia, St. Petersburg, Nevskiy Ave., 22-24.
Konstantin Yu. Boyarsky, reproductologist, Ph.D., Associate Professor of the S.N. Davydov Department of Obstetrics and Gynecology, Pediatric Faculty, I.I. Mechnikov
North-Western State Medical University, Ministry of Health of the Russian Federation; Genesis Reproduction Center, St. Petersburg, konstantinboyarsky@icloud.com,
191015, Russia, St. Petersburg, Kirochnaya str., 64A.
Alexander A. Makolkin, reproductologist, Delta Fertility Clinic, St. Petersburg, 199034, Russia, St. Petersburg, 13th Line of Vasilevsky Island, 10.
Irina O. Zvereva, embryologist, Ph.D., Associate Professor of the Department of Analytical Chemistry named after I.P. Alimarin, Department of Fundamental and Engineering Chemistry, M.V. Lomonosov Institute of Fine Chemical Technologies; Fomin Clinic, Zvereva.sochi2014@gmail.com, 127006, Russia, Moscow, Dolgorukovskaya str., 17-1.
Julia V. Voznesenskaya, reproductologist, Head of the EMC Medical School of Reproduction, EMC Clinic, Moscow, klimka7@yahoo.com,
125040, Russia, Moscow, Pravdy str., 15-1.
Dmitry V. Kholodov, reproductologist, Fomin Clinic, dmitrykholodov@gmail.com, 127006, Russia, Moscow, Dolgorukovskaya str., 17-1.
Authors’ contributions: Kalugina A.A., Boyarsky K.Yu., Makolkin A.A., Zvereva I.O., Voznesenskaya Yu.V., Kholodov D.V.: concept and design of the investigation; material collection and processing; writing the text; editing.
Conflicts of interest: The authors declare that there are no conflicts of interest.
Funding: The investigation has not been sponsored.
For citation: Kalugina A.A., Boyarsky K.Yu., Makolkin A.A., Zvereva I.O., Voznesenskaya Yu.V., Kholodov D.V. Review of the results of clinical studies of follitropin delta in ovarian stimulation protocols. The first experience of its use in Russia.
Akusherstvo i Ginekologiya/ Obstetrics and Gynecology. 2021; 11: 246-264 (in Russian)
https://dx.doi.org/10.18565/aig.2021.11.246-264
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