Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

Infertility, Female Clinical Trial

Official title:

Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088137
• Other study ID #: FSG-03-01
• Status: Completed
• Phase: Phase 3
• Start date: February 8, 2017
• Est. completion date: August 17, 2018

Study information

• Verified date: March 2022
• Source: IVFarma LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: August 17, 2018
• Est. primary completion date: August 17, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Follitropin alfa (Gonal-f)
Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
• Follitropin alfa (Primapur)
Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

Locations

Country	Name	City	State
Russian Federation	AltraVita IVF clinic	Moscow
Russian Federation	Perinatal Medical Center	Moscow
Russian Federation	Clinical Hospital Lapino	Moscow Oblast

Sponsors (3)

Lead Sponsor	Collaborator
IVFarma LLC	BridgePharm LLC, GlobalPharma LLC

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

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, Shalin? R, Polzikov M. A multicenter, rand — View 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

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, V

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	From date of randomization up to 18 days
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	From date of randomization up to 16 days
Secondary	Mature Oocytes	The number of mature oocytes (MII stage of development)	From date of randomization up to 18 days
Secondary	Fertilised Oocytes	The number of fertilised oocytes with the presence of two pronuclei: 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	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)	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)	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)	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)	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)	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)	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	The 10th week after embryo transfer

External Links

•   Abstracts of the 35th Annual Meeting of the ESHRE, Vienna, Austria 24 to 26 June 2019
•   European Journal of Obstetrics & Gynecology and Reproductive Biology Volume 241, October 2019, Pages 6-12