Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®)
A clinical study on the efficacy and safety of follitropin alfa has been conducted. The aim of the study was to confirm the therapeutic equivalence between the follitropin alfa biosimilar (Primapur®) and the reference medication (Gonal-f®) in controlled induction of superovulation within the assiste...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
IRBIS LLC
2018-11-01
|
| Series: | Акушерство, гинекология и репродукция |
| Subjects: | |
| Online Access: | https://www.gynecology.su/jour/article/view/506 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849697359449030656 |
|---|---|
| author | Z. B. Barakhoeva L. A. Vovk I. V. Zorina N. Yu. Belousova T. A. Teterina S. A. Yakovenko V. P. Apryshko Yu. A. Fetisova N. A. Marilova E. G. Morozova M. M. Ovchinnikova M. A. Tishenko Yu. V. Sherbatyuk A. V. Kolotovkina A. A. Miskun G. V. Kasyanova L. G. Sichinava R. I. Shalinа M. A. Polzikov |
| author_facet | Z. B. Barakhoeva L. A. Vovk I. V. Zorina N. Yu. Belousova T. A. Teterina S. A. Yakovenko V. P. Apryshko Yu. A. Fetisova N. A. Marilova E. G. Morozova M. M. Ovchinnikova M. A. Tishenko Yu. V. Sherbatyuk A. V. Kolotovkina A. A. Miskun G. V. Kasyanova L. G. Sichinava R. I. Shalinа M. A. Polzikov |
| author_sort | Z. B. Barakhoeva |
| collection | DOAJ |
| description | A clinical study on the efficacy and safety of follitropin alfa has been conducted. The aim of the study was to confirm the therapeutic equivalence between the follitropin alfa biosimilar (Primapur®) and the reference medication (Gonal-f®) in controlled induction of superovulation within the assisted reproductive technologies (ART) programs. Materials and methods. This multicenter, randomized, blind at the embryological stage, in parallel groups, comparative study of phase III (RCT 754 from 26.10.16/NCT03088137) involved 110 women aged 20-35 years with established causes of infertility (tubal factor, male factor). The patients were randomized into 2 equal groups of 55 participants each. The primary end-point for assessing the therapeutic equivalence was the number of aspirated oocytes. The secondary end-points included the number of fertilized oocytes, the number of days of stimulation, the total dose of the injected drug, the occurrence rate of biochemical and clinical pregnancies. Results. In this study, the follitropin alfa biosimilar was shown to be equivalent to the original follitropin in terms of the number of aspirated oocytes. Also, no statistically significant differences were found in the number of mature and fertilized oocytes, the days of stimulation, the dose of the drug administered during the treatment, and the rate of the onset of biochemical or clinical pregnancy. Conclusion. The therapeutic equivalence between the follitropin alfa containing Primapur® and Gonal-f® has been demonstrated. |
| format | Article |
| id | doaj-art-699f04089b3e418fabec369ccd13372e |
| institution | DOAJ |
| issn | 2313-7347 2500-3194 |
| language | Russian |
| publishDate | 2018-11-01 |
| publisher | IRBIS LLC |
| record_format | Article |
| series | Акушерство, гинекология и репродукция |
| spelling | doaj-art-699f04089b3e418fabec369ccd13372e2025-08-20T03:19:14ZrusIRBIS LLCАкушерство, гинекология и репродукция2313-73472500-31942018-11-0112351610.17749/2313-7347.2018.12.3.005-016463Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®)Z. B. Barakhoeva0L. A. Vovk1I. V. Zorina2N. Yu. Belousova3T. A. Teterina4S. A. Yakovenko5V. P. Apryshko6Yu. A. Fetisova7N. A. Marilova8E. G. Morozova9M. M. Ovchinnikova10M. A. Tishenko11Yu. V. Sherbatyuk12A. V. Kolotovkina13A. A. Miskun14G. V. Kasyanova15L. G. Sichinava16R. I. Shalinа17M. A. Polzikov18«AltraVita» Human Reproduction ClinicPerinatal Medical Center, GC «Mother and Child»«AltraVita» Human Reproduction Clinic«AltraVita» Human Reproduction Clinic«AltraVita» Human Reproduction Clinic«AltraVita» Human Reproduction Clinic; Lomonosov Moscow State University«AltraVita» Human Reproduction ClinicPerinatal Medical Center, GC «Mother and Child»Perinatal Medical Center, GC «Mother and Child»Perinatal Medical Center, GC «Mother and Child»Lapino Clinical Hospital, GC «Mother and Child»Lapino Clinical Hospital, GC «Mother and Child»Lapino Clinical Hospital, GC «Mother and Child»Lapino Clinical Hospital, GC «Mother and Child»Lapino Clinical Hospital, GC «Mother and Child»Lapino Clinical Hospital, GC «Mother and Child»Perinatal Medical Center, GC «Mother and Child»; Russian National Research Medical University named after N.I. Pirogov, Health Ministry of Russian Federation; Moscow Center for Family Planning and Reproduction, Moscow Healthcare DepartmentLapino Clinical Hospital, GC «Mother and Child»; Russian National Research Medical University named after N.I. Pirogov, Health Ministry of Russian Federation; Moscow Center for Family Planning and Reproduction, Moscow Healthcare DepartmentIVFarma LLCA clinical study on the efficacy and safety of follitropin alfa has been conducted. The aim of the study was to confirm the therapeutic equivalence between the follitropin alfa biosimilar (Primapur®) and the reference medication (Gonal-f®) in controlled induction of superovulation within the assisted reproductive technologies (ART) programs. Materials and methods. This multicenter, randomized, blind at the embryological stage, in parallel groups, comparative study of phase III (RCT 754 from 26.10.16/NCT03088137) involved 110 women aged 20-35 years with established causes of infertility (tubal factor, male factor). The patients were randomized into 2 equal groups of 55 participants each. The primary end-point for assessing the therapeutic equivalence was the number of aspirated oocytes. The secondary end-points included the number of fertilized oocytes, the number of days of stimulation, the total dose of the injected drug, the occurrence rate of biochemical and clinical pregnancies. Results. In this study, the follitropin alfa biosimilar was shown to be equivalent to the original follitropin in terms of the number of aspirated oocytes. Also, no statistically significant differences were found in the number of mature and fertilized oocytes, the days of stimulation, the dose of the drug administered during the treatment, and the rate of the onset of biochemical or clinical pregnancy. Conclusion. The therapeutic equivalence between the follitropin alfa containing Primapur® and Gonal-f® has been demonstrated.https://www.gynecology.su/jour/article/view/506follitropin alfarecombinant follicle-stimulating hormonebiosimilarin vitro fertilizationassisted reproductive technologies |
| spellingShingle | Z. B. Barakhoeva L. A. Vovk I. V. Zorina N. Yu. Belousova T. A. Teterina S. A. Yakovenko V. P. Apryshko Yu. A. Fetisova N. A. Marilova E. G. Morozova M. M. Ovchinnikova M. A. Tishenko Yu. V. Sherbatyuk A. V. Kolotovkina A. A. Miskun G. V. Kasyanova L. G. Sichinava R. I. Shalinа M. A. Polzikov Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®) Акушерство, гинекология и репродукция follitropin alfa recombinant follicle-stimulating hormone biosimilar in vitro fertilization assisted reproductive technologies |
| title | Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®) |
| title_full | Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®) |
| title_fullStr | Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®) |
| title_full_unstemmed | Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®) |
| title_short | Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®) |
| title_sort | major results of a phase iii comparative multicenter study on the follitropin alfa biosimilar primapur r and the original follitropin alfa gonal f r |
| topic | follitropin alfa recombinant follicle-stimulating hormone biosimilar in vitro fertilization assisted reproductive technologies |
| url | https://www.gynecology.su/jour/article/view/506 |
| work_keys_str_mv | AT zbbarakhoeva majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT lavovk majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT ivzorina majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT nyubelousova majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT tateterina majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT sayakovenko majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT vpapryshko majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT yuafetisova majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT namarilova majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT egmorozova majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT mmovchinnikova majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT matishenko majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT yuvsherbatyuk majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT avkolotovkina majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT aamiskun majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT gvkasyanova majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT lgsichinava majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT rishalina majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf AT mapolzikov majorresultsofaphaseiiicomparativemulticenterstudyonthefollitropinalfabiosimilarprimapurandtheoriginalfollitropinalfagonalf |