Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institute for Preventive and Social Medicine | OTHER |
Not provided
Not provided
Not provided
Not provided
Aim to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.
A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included:
monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH | The ovarian stimulation (OS) protocols included monotherapy protocols with using follitropin alpha biosimilar only and antagonists/agonists of of gonadotropin-releasing hormone (GnRH): ganirelix, cetrorelix, triptorelin, buserelin. |
| |
| Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH | The OS protocols included: mixed protocols (recombinant with addition of urinary-derived gonadotropins) and antagonists/agonists of GnRH (ganirelix, cetrorelix, triptorelin, buserelin), where follitropin alpha biosimilar used for at least 5 days during OS. |
| |
| Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH | The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH. |
| |
| Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH | The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH. |
| |
| The overall protocols | The OS protocols included: (1) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH, (2) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follitropin Alfa | Drug | Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Oocytes Retrieved | The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the ovulation inducer (HCG or GnRH-agonist). Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). | From date of start of ovarian stimulation with follitropin alpha up to 15 days |
| Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer | Ongoing clinical pregnancy per embryo transfer (detection of gestational sac and heartbeat from 6 weeks after transfer), n (ongoing pregnancy rate per transfer with known outcome, %). Due to delayed embryo transfers, the analysed population for "Ongoing clinical pregnancy per embryo transfer" was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2007 embryo transfers (1542 with known outcome); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2213 embryo transfers (1800 with known outcome); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 1809 embryo transfers (1466 with known outcome) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 404 embryo transfers (334 with known outcome). | At least 6 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Mature Oocytes | Mature oocytes (MII stage of development). Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Women aged 20-43 with established causes of infertility and indications for the use of assisted reproductive technologies (ART) and ovarian stimulation with follitropin alpha.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dilorom Kamilova, PhD | MD Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for reproductive medicine, Barnaul | Barnaul | Russia | ||||
| Center for reproductive medicine, Irkutsk |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | M Polzikov, D Kamilova, M Ovchinnikova, E Mayasina, K Boyarsky, S Nikitin, I Bendusov, M Ganikhina, Z Barakhoeva, E Osina, E Ablyaeva, D Khetagurova, T Ushakova, D Blinov, P-669 "Follitropin": A retrospective, observational study comparing the efficacy of follitropin alpha biosimilar therapy in different ovarian stimulation protocols: real-world data, Human Reproduction, Volume 36, Issue Supplement_1, July 2021, deab130.668. https://doi.org/10.1093/humrep/deab130.668 | ||
| Result | Kamilova D.P., Ovchinnikova M.M., Ablyaeva E.S., Leviashvili M.M., Stuleva N.S., Broitman E.V., Ganikhina M.A., Mayasina E.N., Iskhakova L.F., Boyarskiy K.Yu., Ovsyannikova E.N., Barakhoeva Z.B., Nikitin S.V., Bendusov I.A., Fetisova Yu.A., Yudina M.A., Tararashkina E.S., Khetagurova D.T., Blinov D.V., Polzikov M.A. An observational study "FOLLITROPIN" comparing the efficacy of follitropin alpha biosimilar: the real-world data. Obstetrics, Gynecology and Reproduction. 2021;15(1):5-21. (In Russ.) https://doi.org/10.17749/2313-7347/ob.gyn.rep.2021.212 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All of the analysed subjects underwent OS using GnRH antagonist/agonist protocols, with no restrictions on the OS protocol or food supplements/vitamins.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH | The OS protocols included: mixed protocols (recombinant with addition of urinary-derived gonadotropins) and antagonists/agonists of GnRH (ganirelix, cetrorelix, triptorelin, buserelin), where follitropin alpha biosimilar used for at least 5 days during OS. Follicle Stimulating Hormone/Luteinizing Hormone: Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2021 |
Not provided
Not provided
Not provided
Not provided
|
|
| Follicle Stimulating Hormone/Luteinizing Hormone | Drug | Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH. |
|
|
| Follitropin Alfa | Drug | Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression. |
|
|
| Follitropin Alfa | Drug | Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression. |
|
|
| Follicle Stimulating Hormone/Luteinizing Hormone | Drug | Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH). |
|
|
| From date of start of ovarian stimulation with follitropin alpha up to 15 days |
| Number of Fertilized Oocytes | Fertilization rate (FR) is percentage of transformation of oocytes into two pronuclei (presence of two pronuclei: zygotes with 2PN). Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). | From date of start of ovarian stimulation with follitropin alpha up to 16 days |
| Total Dose of Follitropin Alpha Biosimilar Protocol, IU | Mean dose of follitropin alpha biosimilar for ovarian stimulation. Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). | From date of start of ovarian stimulation with follitropin alpha up to 16 days |
| Irkutsk |
| Russia |
| Clinic "Mother and Child" Kazan | Kazan' | Russia |
| Clinic "Mother and Child" Kostroma | Kostroma | Russia |
| Clinic "Mother and Child" Krasnodar | Krasnodar | Russia |
| Center for reproductive medicine, Krasnoyarsk | Krasnoyarsk | Russia |
| AltraVita IVF clinic | Moscow | Russia |
| Center of Reproductive Medicine and Genetics "Nova Clinic" | Moscow | Russia |
| Clinic "Mather and Child" Lefortovo | Moscow | Russia |
| Clinic "Mather and Child" Savelovskaya | Moscow | Russia |
| Clinic "Mother and Child" Khodynskoe Pole | Moscow | Russia |
| Clinic "Mother and Child" Kuntsevo | Moscow | Russia |
| Clinic "Mother and Child" South-West | Moscow | Russia |
| Clinical Hospital MD GROUP (Perinatal Center on Sevastopolskiy) | Moscow | Russia |
| Clinical Hospital Lapino | Moscow Oblast | Russia |
| Clinic "Mother and Child" | Nizhny Novgorod | Russia |
| Medika-2 | Novokuznetsk | Russia |
| Center for reproductive medicine, Novosibirsk | Novosibirsk | Russia |
| Clinical Hospital "Avicenna" | Novosibirsk | Russia |
| Ceter for reproductive medicine, Omsk | Omsk | Russia |
| Clinic "Mother and Child" Perm | Perm | Russia |
| Clinic "Mother and Child" Rostov-on-Don | Rostov-on-Don | Russia |
| Clinic "Mather and Child" | Ryazan | Russia |
| "Genesis" Reproduction Centre | Saint Petersburg | Russia |
| Clinic "Mother and Child" Saint-Petersburg | Saint Petersburg | Russia |
| Clinical Hospital "Mother and Child" | Samara | Russia |
| Clinic "Mather and Child" Tula | Tula | Russia |
| Clinical Hospital "Mother and Child" | Tyumen | Russia |
| Clinical Hospital "Mother and Child" | Ufa | Russia |
| Clinic "Mother and Child" Vladimir | Vladimir | Russia |
| Clinic "Mather and Child" Vladivostok | Vladivostok | Russia |
| Clinic "Mother and Child" Volgograd | Volgograd | Russia |
| Clinic "Mother and Child" Voronezh | Voronezh | Russia |
| Clinic "Mother and Child" Yaroslavl | Yaroslavl | Russia |
| Clinical Institute of Reproductive Medicine | Yekaterinburg | Russia |
| FG001 | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH | The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression. |
| FG002 | Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH | The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH | The OS protocols included: mixed protocols (recombinant with addition of urinary-derived gonadotropins) and antagonists/agonists of GnRH (ganirelix, cetrorelix, triptorelin, buserelin), where follitropin alpha biosimilar used for at least 5 days during OS. Follicle Stimulating Hormone/Luteinizing Hormone: Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH. |
| BG001 | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH | The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression. |
| BG002 | Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH | The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index (BMI), kg/m^2 | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Duration of infertility, years | Mean | Standard Deviation | years |
| |||||||||||||||
| IVF attempt | Mean | Standard Deviation | number of IVF attempts |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Oocytes Retrieved | The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the ovulation inducer (HCG or GnRH-agonist). Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). | Arm "Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH" is combined group for primary and secondary outcome measures and consist of patients from "Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH" and "Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH". | Posted | Mean | Standard Deviation | The total number of retrieved oocytes | From date of start of ovarian stimulation with follitropin alpha up to 15 days |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer | Ongoing clinical pregnancy per embryo transfer (detection of gestational sac and heartbeat from 6 weeks after transfer), n (ongoing pregnancy rate per transfer with known outcome, %). Due to delayed embryo transfers, the analysed population for "Ongoing clinical pregnancy per embryo transfer" was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2007 embryo transfers (1542 with known outcome); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2213 embryo transfers (1800 with known outcome); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 1809 embryo transfers (1466 with known outcome) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 404 embryo transfers (334 with known outcome). | Arm "Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH" is combined group for primary and secondary outcome measures and consist of patients from "Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH" and "Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH". | Posted | Number | 95% Confidence Interval | Percetnage of patients (%) | At least 6 weeks after embryo transfer |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Mature Oocytes | Mature oocytes (MII stage of development). Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). | Arm "Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH" is combined group for primary and secondary outcome measures and consist of patients from "Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH" and "Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH". | Posted | Mean | Standard Deviation | Number of mature oocytes | From date of start of ovarian stimulation with follitropin alpha up to 15 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Fertilized Oocytes | Fertilization rate (FR) is percentage of transformation of oocytes into two pronuclei (presence of two pronuclei: zygotes with 2PN). Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). | Arm "Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH" is combined group for primary and secondary outcome measures and consist of patients from "Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH" and "Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH". | Posted | Mean | Standard Deviation | zygotes with 2PN | From date of start of ovarian stimulation with follitropin alpha up to 16 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Dose of Follitropin Alpha Biosimilar Protocol, IU | Mean dose of follitropin alpha biosimilar for ovarian stimulation. Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). | Posted | Mean | Standard Deviation | IU (International Units) | From date of start of ovarian stimulation with follitropin alpha up to 16 days |
|
The time frame was 20 days: ovarian stimulation (up to 15 days) till the day of embryo transfer (up to 5 days).
Serious adverse events collection (hospitalizations). Due to overall ovarian stimulation protocols consist of follitropin alpha biosimilar treatment for at least 5 days, the adverse events were combined in one group ("Overall protocols"). The questionary was not include the enquiry for exact description of ovarian stimulation protocol (or treatment).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Overall Protocols | The overall protocols (groups) were combined and analysed for Serious Adverse Events and other (not including serious) adverse events. Due to overall ovarian stimulation protocols consist of follitropin alpha biosimilar treatment for at least 5 days, the adverse events were combined in one group to analyse the safety of follitropin alpha biosimilar treatment not in relation to protocol of ovarian stimulation and other medication. | 0 | 5,484 | 0 | 5,484 | 657 | 5,484 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment | Injection site pain was classified as skin and subcutaneous tissue disorders and included redness, pain, bruising and irritation without differentiation. |
|
The real-world patient data analysed in this study were representative, showing the ability of follitropin biosimilars to develop both folliculogenesis and clinical pregnancy in a nonselected population. Additional comparative studies are needed to confirm the efficacy of the biosimilars in patients with classified types of infertility causes, including unexplained infertility.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| General Manager | IVFarma LLC | +74996455342 | info@ivfarma.ru |
| Jun 24, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007246 | Infertility |
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C571801 | follitropin alfa |
| D059451 | Biosimilar Pharmaceuticals |
| D008596 | Menotropins |
| C571802 | follitropin beta |
| D037101 | Luteinizing Hormone, beta Subunit |
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007986 | Luteinizing Hormone |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH |
The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression. Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) in 30 participants (or 4,4%), the analysed population was 646 participants. |
| OG004 | The Overall Protocols | The OS protocols included: (1) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH, (2) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH Follicle Stimulating Hormone/Luteinizing Hormone: Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH). |
| Other |
| OG001 | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH | The ovarian stimulation (OS) protocols included monotherapy protocols with using follitropin alpha biosimilar only and antagonists/agonists of of gonadotropin-releasing hormone (GnRH): ganirelix, cetrorelix, triptorelin, buserelin. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH. |
| OG002 | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH | The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression. |
| OG003 | Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH | The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression. |
| OG004 | The Overall Protocols | The OS protocols included: (1) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH, (2) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH Follicle Stimulating Hormone/Luteinizing Hormone: Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH). |
|
|
|
| OG001 | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH | The ovarian stimulation (OS) protocols included monotherapy protocols with using follitropin alpha biosimilar only and antagonists/agonists of of gonadotropin-releasing hormone (GnRH): ganirelix, cetrorelix, triptorelin, buserelin. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH. |
| OG002 | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH | The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression. |
| OG003 | Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH | The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression. |
| OG004 | The Overall Protocols | The OS protocols included: (1) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH, (2) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH Follicle Stimulating Hormone/Luteinizing Hormone: Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH). |
|
|
|
| OG001 | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH | The ovarian stimulation (OS) protocols included monotherapy protocols with using follitropin alpha biosimilar only and antagonists/agonists of of gonadotropin-releasing hormone (GnRH): ganirelix, cetrorelix, triptorelin, buserelin. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH. |
| OG002 | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH | The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression. |
| OG003 | Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH | The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression. |
| OG004 | The Overall Protocols | The OS protocols included: (1) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH, (2) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH Follicle Stimulating Hormone/Luteinizing Hormone: Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH). |
|
|
|
| OG001 | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH | The ovarian stimulation (OS) protocols included monotherapy protocols with using follitropin alpha biosimilar only and antagonists/agonists of of gonadotropin-releasing hormone (GnRH): ganirelix, cetrorelix, triptorelin, buserelin. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH. |
| OG002 | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH | The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression. |
| OG003 | Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH | The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH. Follitropin Alfa: Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression. |
| OG004 | The Overall Protocols | The OS protocols included: (1) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH, (2) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH Follicle Stimulating Hormone/Luteinizing Hormone: Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH). |
|
|
|