Follitropin delta in IVF/ICSI programs

Krasnopolskaya K.V., Isakova K.M., Ershova I.Yu., Shostenko L.V., Shishkina A.V.

1) Department of Reproductology, Moscow Regional Research Institute of Obstetrics and Gynecology, Moscow, Russia; 2) PRIOR CLINIC Reproductive Health Clinic, Moscow, Russia

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 μg 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 225 IU.
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 of 10.9 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.

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About the Authors

Ksenia V. Krasnopolskaya, Corresponding Member of the RAS, Dr. Med. Sci., Professor, Head of the Department of Reproductology, Moscow Regional Research Institute of Obstetrics and Gynecology, 101000, Russia, Moscow, Pokrovka str., 22a; Head of the Department of High Reproductive Technologies, obstetrician-gynecologist,
PRIOR CLINIC, 101000, Russia, Moscow, Potapovskiy pereulok, 4 b. 1, +7(495)980-40-28, guzmoniiag@gmail.com, https://orchid.org/0000-0002-1275-9220
Kamila M. Isakova, PhD, obstetrician-gynecologist, Researcher, Moscow Regional Scientific Research Institute of Obstetrics and Gynecology; Chief Physician,
BioOptima Clinic of Reproductive Health, +7(903)677-39-89, isa-kama@yandex.ru, https://orcid.org/0000-0001-6194-1654, 101000, Russia, Moscow, Pokrovka str., 22A.
Irina Yu. Ershova, PhD, Researcher at the Department of Reproduction, Moscow Regional Research Institute of Obstetrics and Gynecology,
101000, Russia, Moscow, Pokrovka str., 22A; obstetrician-gynecologist, PRIOR CLINIC, 101000, Russia, Moscow, Potapovskiy pereulok, 4 b. 1, +7(495)980-40-28,
i3236987@gmail.com, https://orchid.org/0000-0001-9327-0656
Lidiya V. Shostenko, obstetrician-gynecologist, postgraduate student of the Department of Reproduction, Moscow Regional Scientific Research Institute of Obstetrics and Gynecology, +7(916)216-94-83, lidsonnn@gmail.com, https://orcid.org/0000-0001-5002-9344, 101000, Russia, Moscow, Pokrovka str., 22A.
Anna V. Shishkina, obstetrician-gynecologist, postgraduate student of the Department of Reproduction, Moscow Regional Scientific Research Institute of Obstetrics and Gynecology, +7(915)304-94-58, anya.shostenko@yahoo.com, https://orcid.org/0000-0002-4733-5284, 101000, Russia, Moscow, Pokrovka str., 22А.

Authors' contributions: Krasnopolskaya K.V. – concept and design of the study; Krasnopolskaya K.V., Isakova K.M., Ershova I.Yu., Shishkina A.V., Shostenko L.V. – data collection and processing; Shostenko L.V., Shishkina A.V., Isakova K.M. – text writing; Krasnopolskaya K.V., Ershova I.Yu. – editing.
Conflicts of interest: The authors declare that there are no conflicts of interest.
Funding: The investigation has not been sponsored.
Patient Consent for Publication: All patients provided informed consent for the publication of their data.
Authors' Data Sharing Statement: The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator.
For citation: Krasnopolskaya K.V., Isakova K.M., Ershova I.Yu.,
Shostenko L.V., Shishkina A.V. Follitropin delta in IVF/ICSI programs.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2022; 12: 167-176 (in Russian)
http://dx.doi.org/10.18565/aig.2022.302

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