Therapeutic equivalence evaluation of bioequivalent and original micronized vaginal progesterone preparations in hormone replacement therapy in women undergoing frozen-thawed embryo transfer
There is currently no evidence for the clinical benefits of using bioequivalent micronized progesterone preparation produced in Russia compared to the original preparation for post-transfer support after the frozen-thawed embryo transfer. Therefore, it is important to confirm the therapeutic equivalence of the Russian preparation in the programs of assisted reproductive technologies (ART).Bashmakova N.V., Khramtsova A.Yu., Dzhalilova E.R.
Objective: To perform a comparative analysis of the effectiveness of frozen-thawed embryo transfer programs and pregnancy outcomes in women who took bioequivalent and original micronized vaginal progesterone preparations for the secretory transformation of the endometrium and post-transfer support.
Materials and methods: The study included 93 infertile women who had frozen-thawed own embryo transfer with hormone replacement therapy cycle in the Assisted Reproduction Department, Urals Scientific Research Institute for Maternal and Child Care. The first group consisted of 45 patients who took Russian bioequivalent micronized progesterone preparation “DlyJens pro” (600 mg/day intravaginally) for full secretory transformation of the endometrium, the second group included 48 patients who were prescribed original micronized vaginal progesterone preparation (600 mg/day intravaginally).
Results: The implantation rate was 22/45 (48.89%) patients in group 1, it was 21/48 (43.75%) in group 2. The clinical pregnancy rate was higher in group of patients who took the bioequivalent micronized progesterone preparation than in group 2 and it was 19/45 (42.22%), however, no statistical differences were found (p=0.796). There was no statistical difference in the rate of multiple pregnancies in both groups (p=0.462). Multiple pregnancies were detected in 4/19 (21%) patients in group 1 and in 6/19 (31.6%) patients in group 2.
Conclusion: The data obtained in the study on the outcomes of frozen-thawed embryo transfer programs showed comparable effectiveness of the bioequivalent and original micronized progesterone preparations. The study demonstrated the possibility of using both original and bioequivalent micronized vaginal progesterone preparations in hormone replacement therapy cycles in assisted reproduction.
Authors’ contributions: Bashmakova N.V. – developing the concept and design of the study, editing; Bashmakova N.V., Khramtsova A.Yu., Dzhalilova E.R. – collecting and processing the material; Khramtsova A.Yu. – statistical data processing; Bashmakova N.V., Khramtsova A.Yu. – writing the text.
Conflicts of interest: The authors declare that there are no conflicts of interest.
Funding: The study was conducted without sponsorship.
Ethical Approval: The study was approved by the Ethical Review Board of the Urals Scientific Research Institute for Maternal and Child Care, Ministry of Health of Russia.
Patient Consent for Publication: The patients provided an 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: Bashmakova N.V., Khramtsova A.Yu., Dzhalilova E.R.
Therapeutic equivalence evaluation of bioequivalent and original micronized vaginal progesterone preparations in hormone replacement therapy in women undergoing frozen-thawed embryo transfer.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2023; 9: 164-169 (in Russian)
https://dx.doi.org/10.18565/aig.2023.197
Keywords
assisted reproductive technologies (ART)
frozen-thawed embryo transfer
bioequivalence
micronized progesterone
pregnancy after ART
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Received 18.08.2023
Accepted 12.09.2023
About the Authors
Nadezda V. Bashmakova, Dr. Med. Sci., Professor, Honored Doctor of the Russian Federation, Head of the Department of Assisted Reproductive Technologies, Chief obstetrician-gynecologist of the Ural Federal District, Chief Researcher of Ural Research Institute of Maternity and Child Care, Ministry of Health of Russia,620028, Russia, Yekaterinburg, Repin str., 1, +7(343)371-87-68, BashmakovaNV@niiomm.ru, SPIN РИНЦ: 9604-0089, Scopus Author ID: 270915
Alexandra Yu. Khramtsova, PhD, obstetrician-gynecologist, researcher, Department of Assisted Reproductive Technologies, Ural Research Institute of Maternity and Child Care, Ministry of Health of Russia, 620028, Russia, Yekaterinburg, Repin str., 1, +7(912)68-26-726, aleksaxr@mail.ru, SPIN РИНЦ: 2467-5326,
Scopus Author ID: 57214320389, 0000- https://orcid.org/0002-4304-3516
El'mira R. Dzhalilova, obstetrician-gynecologist, Department of Assisted Reproductive Technologies, graduate student, Ural Research Institute of Maternity and Child Care, Ministry of Health of Russia, 620109, Russia, Yekaterinburg, Repin str., 17, +7(343)232-55-12, vip.dzhalilova2017@mail.ru, https://orcid.org/0000-0002-4965-6663
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