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| Name | Class |
|---|---|
| BridgePharm LLC | UNKNOWN |
| GlobalPharma LLC | UNKNOWN |
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The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primapur (Follitropin alfa) | Experimental |
| |
| Gonal-f (Follitropin alfa) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follitropin alfa (Gonal-f) | Drug | Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oocytes (Intention-to-Treat, ITT) | The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes. | From date of randomization up to 18 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Follicles With Size ≥ 16 mm | The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration | From date of randomization up to 16 days |
| Mature Oocytes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AltraVita IVF clinic | Moscow | Russia | ||||
| Perinatal Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | M. Polzikov, Z. Barakhoeva, S. Yakovenko, M. Ovchinnikova, L.Vovk, Y. Fetisova. A multicenter, randomized study comparing the efficacy of follitropin alpha biosimilar and the original follitropin alpha. Abstracts of the 35th Annual Meeting of the ESHRE, Vienna, Austria 24 to 26 June 2019 (abstract P-649), Human Reproduction, 2019; Vol. 34, Suppl. 1, p. i439. | ||
| 31400644 | Result | Barakhoeva Z, Vovk L, Fetisova Y, Marilova N, Ovchinnikova M, Tischenko M, Scherbatyuk Y, Kolotovkina A, Miskun A, Kasyanova G, Teterina T, Zorina I, Belousova N, Morozova E, Yakovenko S, Apryshko V, Sichinava L, Shalinsmall a, Cyrillic R, Polzikov M. A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:6-12. doi: 10.1016/j.ejogrb.2019.07.032. Epub 2019 Jul 26. | |
| Result | Barakhoeva Z.B., Vovk L.A., Zorina I.V., Belousova N.Y., Teterina T.A., Yakovenko S.A., Apryshko V.P., Fetisova Y.A., Marilova N.A., Morozova E.G., Ovchinnikova M.M., Tishenko M.A., Sherbatyuk Y.V., Kolotovkina A.V., Miskun A.A., Kasyanova G.V., Sichinava L.G., Shalinа R.I., Polzikov M.A. Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®). Akusherstvo, ginekologiya i reprodukciya. 2018;12(3):5-16. (In Russ.) https://doi.org/10.17749/2313-7347.2018.12.3.005-016 |
| Label | URL |
|---|---|
| European Journal of Obstetrics \& Gynecology and Reproductive Biology Volume 241, October 2019, Pages 6-12 | View source |
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Of 118 participants: 8 were reported as screening failures prior the group assignment.
Subjects were screened and enrolled at 3 In Vitro Fertilisation (IVF) centers in Russian Federation from 08.02.2017 - 17.08.2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Primapur (Follitropin Alfa) | Follitropin alfa (Primapur): Subcutaneous injection (pen-injector), fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation |
| FG001 | Gonal-f (Follitropin Alfa) | Follitropin alfa (Gonal-f): Subcutaneous injection (pen-injector), fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primapur (Follitropin Alfa) | Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation |
| BG001 | Gonal-f (Follitropin Alfa) |
| 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) |
| 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 | Oocytes (Intention-to-Treat, ITT) | The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes. | Intention-to-Treat | Posted | Mean | Standard Deviation | Number of retrieved oocytes | From date of randomization up to 18 days |
|
1 year, 6 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primapur (Follitropin Alfa) | Follitropin alfa (Primapur): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian hyperstymulation syndrome | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment | Patients with positive pregnancy test |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spontaneous miscarriage | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mikhail Polzikov (PhD) | IVFarma LLC | +74996455342 | 1 | mikhail.polzikov@ivfarma.ru |
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| 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 | Oct 4, 2016 | Feb 22, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C571801 | follitropin alfa |
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| Follitropin alfa (Primapur) | Drug | Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation |
|
The number of mature oocytes (MII stage of development)
| From date of randomization up to 18 days |
| Fertilised Oocytes | The number of fertilised oocytes with the presence of two pronuclei: 2PN | From date of randomization up to 19 days |
| Percentage of Patients With Embryo Transfer | The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up | From date of randomization up to 25 days |
| Total Dose of Follitropin Alfa | The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU) | From date of randomization up to 16 days |
| Number of Days of Follitropin Alfa Treatment | The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation) | From date of randomization up to 16 days |
| Number of Patients With Follitropin Alfa Dose Correction | The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU) | From date of randomization up to 16 days |
| Number of Patients With Cycle Cancellation | The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation) | From date of randomization up to 16 days |
| Number of No-responders | The number of patients with no response to follitropin alfa treatment (absence of growing follicles, no any oocytes obtained at the day of ovum pick-up) | From date of randomization up to 8 days |
| Percentage of Patients With Serum hCG More Than 25 IU/l | Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer) | From date of randomization up to 42 days |
| Percentage of Patients With the Evidence for Clinical Pregnancy | Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity | The 10th week after embryo transfer |
| Moscow |
| Russia |
| Clinical Hospital Lapino | Moscow Oblast | Russia |
| 35222266 | Derived | Polzikov M, Blinov D, Barakhoeva Z, Vovk L, Fetisova Y, Ovchinnikova M, Tischenko M, Zorina I, Yurasov V, Ushakova T, Sergeyev O. Association of the Serum Folate and Total Calcium and Magnesium Levels Before Ovarian Stimulation With Outcomes of Fresh In Vitro Fertilization Cycles in Normogonadotropic Women. Front Endocrinol (Lausanne). 2022 Feb 11;13:732731. doi: 10.3389/fendo.2022.732731. eCollection 2022. |
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
| BG002 | Total | Total of all reporting groups |
| 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/m2 | Mean | Standard Deviation | kg/m2 |
|
| Duration of infertility | month | Mean | Standard Deviation | month |
|
| Antral follicle | Mean (Standard Deviation) | Mean | Standard Deviation | Number of antral follicles |
|
| Anti-mullerian hormone (AMH) | Mean (Standard deviation) | Mean | Standard Deviation | ng per ml |
|
| Follicle stimulating hormone (FSH) | IU per l | Mean | Standard Deviation | IU/l |
|
| Estradiol | Mean | Standard Deviation | pg/ml |
|
| Cause of infertility | Patients with the determined cause of infertility | Count of Participants | Participants |
|
Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
|
|
|
| Secondary | Number of Follicles With Size ≥ 16 mm | The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration | Intention-to-Treat | Posted | Mean | Standard Deviation | Number of follicles | From date of randomization up to 16 days |
|
|
|
|
| Secondary | Mature Oocytes | The number of mature oocytes (MII stage of development) | Intention-to-Treat | Posted | Mean | Standard Deviation | Number of mature oocytes (MII stage) | From date of randomization up to 18 days |
|
|
|
|
| Secondary | Fertilised Oocytes | The number of fertilised oocytes with the presence of two pronuclei: 2PN | Intention-to-Treat | Posted | Mean | Standard Deviation | Number of oocytes with 2PN | From date of randomization up to 19 days |
|
|
|
|
| Secondary | Percentage of Patients With Embryo Transfer | The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up | Per Protocol | Posted | Count of Participants | Participants | From date of randomization up to 25 days |
|
|
|
|
| Secondary | Total Dose of Follitropin Alfa | The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU) | Intention-to-Treat | Posted | Mean | Standard Deviation | Total dose (IU) | From date of randomization up to 16 days |
|
|
|
|
| Secondary | Number of Days of Follitropin Alfa Treatment | The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation) | Intention-to-Treat | Posted | Mean | Standard Deviation | Days | From date of randomization up to 16 days |
|
|
|
|
| Secondary | Number of Patients With Follitropin Alfa Dose Correction | The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU) | Intention-to-Treat | Posted | Count of Participants | Participants | From date of randomization up to 16 days |
|
|
|
|
| Secondary | Number of Patients With Cycle Cancellation | The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation) | Intention-to-Treat | Posted | Count of Participants | Participants | From date of randomization up to 16 days |
|
|
|
| Secondary | Number of No-responders | The number of patients with no response to follitropin alfa treatment (absence of growing follicles, no any oocytes obtained at the day of ovum pick-up) | Intention-to-Treat | Posted | Count of Participants | Participants | From date of randomization up to 8 days |
|
|
|
| Secondary | Percentage of Patients With Serum hCG More Than 25 IU/l | Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer) | Per Protocol | Posted | Number | 95% Confidence Interval | Percentage of patients (%) | From date of randomization up to 42 days |
|
|
|
|
| Secondary | Percentage of Patients With the Evidence for Clinical Pregnancy | Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity | Per Protocol | Posted | Number | 95% Confidence Interval | Percentage of patients (%) | The 10th week after embryo transfer |
|
|
|
|
| 0 |
| 55 |
| 2 |
| 55 |
| 21 |
| 55 |
| EG001 | Gonal-f (Follitropin Alfa) | Follitropin alfa (Gonal-f): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation | 0 | 55 | 2 | 55 | 13 | 55 |
|
| Iatrogenic injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment | iatrogenic bladder injury during transvaginal ovarian puncturing |
|
| Threatened miscarriage | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | Systematic Assessment |
|
| Early Toxicosis During Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | Systematic Assessment |
|
| Abnormal vaginal bleeding | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | Systematic Assessment |
|
| Menses | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment | Patients with negative pregnancy test |
|
| Decrease in breast sensitivity | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Spotting | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | Systematic Assessment |
|
| Lower abdominal pain | Pregnancy, puerperium and perinatal conditions | MedDRA 10.0 | Systematic Assessment |
|
| Lower abdominal pain | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pains in the lower abdomen | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Laboratory investigations | Investigations | MedDRA 10.0 | Systematic Assessment | Erythrocyte level increase in urine |
|
| Sternum pain | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Drowsiness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abnormal vaginal bleeding | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Spotting | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D000091662 | Genital Diseases |
| D007246 | Infertility |