Clinical trial NCT03088137: Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Official title: Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility, Female
Keywords: in vitro fertilization
Lead sponsor: IVFarma LLC
Sponsor class: INDUSTRY
Collaborators: name: BridgePharm LLC
name: GlobalPharma LLC
First posted: 2017-03-23
Enrollment: 118
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Infertility due to tubal factor and/or male factor
* Age between 20 and 35 years with regular menstrual cycles of 21-35 days
* First or second cycle in the present series of ART
* BMI (body mass index) ≥ 18 ≤ 30 kg/m2
* Basal FSH (follicle stimulating hormone) \< 10 IU/L (cycle day 2-5)
* E2 (estradiol) levels \< 50pg/mL (cycle day 2)
* AMH (anti-mullerian hormone) ≥ 1.0 ng/ml
* Antral follicle ≥ 4 to ≤ 15 follicles (both ovaries)
* Presence of both ovaries and normal uterine cavity
* Informed consent

Exclusion Criteria:

* Presence of pregnancy
* Hypersensitivity to follitropin alfa
* Ovarian cysts
* History of ≥2 succeeding ART (assisted reproductive technology) cycles IVF (in vitro fertilization) and/or ICSI (Intracytoplasmic sperm injection) before the study cycle
* Previous history of severe ovarian hyperstimulation syndrome
* Presence of polycystic ovaries (PCO)
* Presence of endometriosis and hydrosalpinx
* Presence of uterine disorders
* History of poor (\< 4 oocytes) or hyper (\> 25 oocytes) responses to FSH treatment at dose 150 IU and GnRH-antagonist (gonadotropin-releasing hormone) protocol
* Premature ovarian failure
* Ectopic pregnancy (3 month before the study cycle)
* Presence of clinically significant systemic disease
* Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
* Presence of endocrine disorder
* Neoplasia
* Male infertility without mobile spermatozoa in the ejaculate, that need MESA (Microsurgical epididymal sperm aspiration)/TESE (testicular sperm extraction)/TESA (testicular sperm aspiration)
* Smoking \> 10 cigarettes/day
* Narcomania, alcoholism
* Planned PGS (preimplantation genetic screeneing) /PGD (preimplantation genetic diagnosis)

Primary outcomes:
measure: Oocytes (Intention-to-Treat, ITT)
timeFrame: From date of randomization up to 18 days
Secondary outcomes:
measure: Number of Follicles With Size ≥ 16 mm
timeFrame: From date of randomization up to 16 days
measure: Mature Oocytes
timeFrame: From date of randomization up to 18 days
measure: Fertilised Oocytes
timeFrame: From date of randomization up to 19 days
measure: Percentage of Patients With Embryo Transfer
timeFrame: From date of randomization up to 25 days
measure: Total Dose of Follitropin Alfa
timeFrame: From date of randomization up to 16 days
measure: Number of Days of Follitropin Alfa Treatment
timeFrame: From date of randomization up to 16 days
measure: Number of Patients With Follitropin Alfa Dose Correction
timeFrame: From date of randomization up to 16 days
measure: Number of Patients With Cycle Cancellation
timeFrame: From date of randomization up to 16 days
measure: Number of No-responders
timeFrame: From date of randomization up to 8 days
measure: Percentage of Patients With Serum hCG More Than 25 IU/l
timeFrame: From date of randomization up to 42 days
measure: Percentage of Patients With the Evidence for Clinical Pregnancy
timeFrame: The 10th week after embryo transfer
Other outcomes:
Locations:
city: Moscow Oblast
country: Russian Federation
facility: Clinical Hospital Lapino
city: Moscow
country: Russian Federation
facility: AltraVita IVF clinic
city: Moscow
country: Russian Federation
facility: Perinatal Medical Center
Study officials:
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.