Clinical trial NCT04854707: An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
Official title: An Observational Study "FOLLITROPIN" Comparing the Efficacy of Follitropin Alpha Biosimilar: the Real-world Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reproductive Issues
Reproductive Disorder
Fertility Disorders
Fertility Issues
Gynecologic Disease
IVF
Keywords: follitropin alpha
follicle-stimulating hormone
in vitro fertilization
assisted reproductive technologies
biosimilar
follitropin alfa
real-world data
Lead sponsor: IVFarma LLC
Sponsor class: INDUSTRY
Collaborators: name: Institute for Preventive and Social Medicine
First posted: 2021-04-22
Enrollment: 5484
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: Aim to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women with established causes of infertility and indications for the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation "On the use of assisted reproductive technologies, contraindications and limitations to their use" No. 107 n dated August 30, 2012.
* Infertility due to female and/or male factor.
* Presence of ovaries accessible for aspiration of follicles.
* Anatomical and functional capability of uterus to bear pregnancy.

Exclusion Criteria:

* Women with established contraindications to the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation "On the use of assisted reproductive technologies, contraindications and limitations to their use" No. 107 n dated August 30, 2012.
* Presence of pregnancy
* Hypersensitivity to follitropin alfa or excipients.
* Ovarian cysts (not associated with polycystic ovarian syndrome), uterine hemorrhage of unclear etiology
* Premature ovarian failure
* Presence of clinically significant systemic disease
* Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
* Neoplasia
* Narcomania, alcoholism

Primary outcomes:
measure: Number of Oocytes Retrieved
timeFrame: From date of start of ovarian stimulation with follitropin alpha up to 15 days
measure: Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer
timeFrame: At least 6 weeks after embryo transfer
Secondary outcomes:
measure: Number of Mature Oocytes
timeFrame: From date of start of ovarian stimulation with follitropin alpha up to 15 days
measure: Number of Fertilized Oocytes
timeFrame: From date of start of ovarian stimulation with follitropin alpha up to 16 days
measure: Total Dose of Follitropin Alpha Biosimilar Protocol, IU
timeFrame: From date of start of ovarian stimulation with follitropin alpha up to 16 days
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Center for reproductive medicine, Barnaul
city: Ekaterinburg
country: Russian Federation
facility: Clinical Institute of Reproductive Medicine
city: Irkutsk
country: Russian Federation
facility: Center for reproductive medicine, Irkutsk
city: Kazan
country: Russian Federation
facility: Clinic "Mother and Child" Kazan
city: Kostroma
country: Russian Federation
facility: Clinic "Mother and Child" Kostroma
city: Krasnodar
country: Russian Federation
facility: Clinic "Mother and Child" Krasnodar
city: Krasnoyarsk
country: Russian Federation
facility: Center for reproductive medicine, Krasnoyarsk
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: Center of Reproductive Medicine and Genetics "Nova Clinic"
city: Moscow
country: Russian Federation
facility: Clinic "Mather and Child" Lefortovo
city: Moscow
country: Russian Federation
facility: Clinic "Mather and Child" Savelovskaya
city: Moscow
country: Russian Federation
facility: Clinic "Mother and Child" Khodynskoe Pole
city: Moscow
country: Russian Federation
facility: Clinic "Mother and Child" Kuntsevo
city: Moscow
country: Russian Federation
facility: Clinic "Mother and Child" South-West
city: Moscow
country: Russian Federation
facility: Clinical Hospital MD GROUP (Perinatal Center on Sevastopolskiy)
city: Nizhny Novgorod
country: Russian Federation
facility: Clinic "Mother and Child"
city: Novokuznetsk
country: Russian Federation
facility: Medika-2
city: Novosibirsk
country: Russian Federation
facility: Center for reproductive medicine, Novosibirsk
city: Novosibirsk
country: Russian Federation
facility: Clinical Hospital "Avicenna"
city: Omsk
country: Russian Federation
facility: Ceter for reproductive medicine, Omsk
city: Perm
country: Russian Federation
facility: Clinic "Mother and Child" Perm
city: Rostov-on-Don
country: Russian Federation
facility: Clinic "Mother and Child" Rostov-on-Don
city: Ryazan'
country: Russian Federation
facility: Clinic "Mather and Child"
city: Saint Petersburg
country: Russian Federation
facility: "Genesis" Reproduction Centre
city: Saint Petersburg
country: Russian Federation
facility: Clinic "Mother and Child" Saint-Petersburg
city: Samara
country: Russian Federation
facility: Clinical Hospital "Mother and Child"
city: Tula
country: Russian Federation
facility: Clinic "Mather and Child" Tula
city: Tyumen
country: Russian Federation
facility: Clinical Hospital "Mother and Child"
city: Ufa
country: Russian Federation
facility: Clinical Hospital "Mother and Child"
city: Vladimir
country: Russian Federation
facility: Clinic "Mother and Child" Vladimir
city: Vladivostok
country: Russian Federation
facility: Clinic "Mather and Child" Vladivostok
city: Volgograd
country: Russian Federation
facility: Clinic "Mother and Child" Volgograd
city: Voronezh
country: Russian Federation
facility: Clinic "Mother and Child" Voronezh
city: Yaroslavl
country: Russian Federation
facility: Clinic "Mother and Child" Yaroslavl
Study officials:
affiliation: MD Medical Group
name: Dilorom Kamilova, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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