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An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data

NCT ID: NCT04854707

Last Updated: 2021-10-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5484 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-12

Study Completion Date

2021-01-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Reproductive Issues Reproductive Disorder Fertility Disorders Fertility Issues Gynecologic Disease IVF

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Intervention Type 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.

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

Intervention Type 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.

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

Intervention Type 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.

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

Intervention Type 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.

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

Intervention Type 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).

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

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).

Intervention Type DRUG

Other Intervention Names

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Primapur Biosimilar Follitropin beta Follitropin alfa + Lutropin alfa Corifollitropin alfa Menotropins Follitropin alfa Follitropin alfa biosimilar Primapur Biosimilar Follitropin alfa biosimilar Primapur Biosimilar Follitropin alfa biosimilar Follitropin beta Corifollitropin alfa Follitropin alfa + Lutropin alfa Menotropins Follitropin alfa biosimilar Follitropin alfa

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institute for Preventive and Social Medicine

OTHER

Sponsor Role collaborator

IVFarma LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dilorom Kamilova, PhD

Role: PRINCIPAL_INVESTIGATOR

MD Medical Group

Locations

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Center for reproductive medicine, Barnaul

Barnaul, , Russia

Site Status

Center for reproductive medicine, Irkutsk

Irkutsk, , Russia

Site Status

Clinic "Mother and Child" Kazan

Kazan', , Russia

Site Status

Clinic "Mother and Child" Kostroma

Kostroma, , Russia

Site Status

Clinic "Mother and Child" Krasnodar

Krasnodar, , Russia

Site Status

Center for reproductive medicine, Krasnoyarsk

Krasnoyarsk, , Russia

Site Status

AltraVita IVF clinic

Moscow, , Russia

Site Status

Center of Reproductive Medicine and Genetics "Nova Clinic"

Moscow, , Russia

Site Status

Clinic "Mather and Child" Lefortovo

Moscow, , Russia

Site Status

Clinic "Mather and Child" Savelovskaya

Moscow, , Russia

Site Status

Clinic "Mother and Child" Khodynskoe Pole

Moscow, , Russia

Site Status

Clinic "Mother and Child" Kuntsevo

Moscow, , Russia

Site Status

Clinic "Mother and Child" South-West

Moscow, , Russia

Site Status

Clinical Hospital MD GROUP (Perinatal Center on Sevastopolskiy)

Moscow, , Russia

Site Status

Clinical Hospital Lapino

Moscow Oblast, , Russia

Site Status

Clinic "Mother and Child"

Nizhny Novgorod, , Russia

Site Status

Medika-2

Novokuznetsk, , Russia

Site Status

Center for reproductive medicine, Novosibirsk

Novosibirsk, , Russia

Site Status

Clinical Hospital "Avicenna"

Novosibirsk, , Russia

Site Status

Ceter for reproductive medicine, Omsk

Omsk, , Russia

Site Status

Clinic "Mother and Child" Perm

Perm, , Russia

Site Status

Clinic "Mother and Child" Rostov-on-Don

Rostov-on-Don, , Russia

Site Status

Clinic "Mather and Child"

Ryazan, , Russia

Site Status

"Genesis" Reproduction Centre

Saint Petersburg, , Russia

Site Status

Clinic "Mother and Child" Saint-Petersburg

Saint Petersburg, , Russia

Site Status

Clinical Hospital "Mother and Child"

Samara, , Russia

Site Status

Clinic "Mather and Child" Tula

Tula, , Russia

Site Status

Clinical Hospital "Mother and Child"

Tyumen, , Russia

Site Status

Clinical Hospital "Mother and Child"

Ufa, , Russia

Site Status

Clinic "Mother and Child" Vladimir

Vladimir, , Russia

Site Status

Clinic "Mather and Child" Vladivostok

Vladivostok, , Russia

Site Status

Clinic "Mother and Child" Volgograd

Volgograd, , Russia

Site Status

Clinic "Mother and Child" Voronezh

Voronezh, , Russia

Site Status

Clinic "Mother and Child" Yaroslavl

Yaroslavl, , Russia

Site Status

Clinical Institute of Reproductive Medicine

Yekaterinburg, , Russia

Site Status

Countries

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Russia

References

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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

Reference Type 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

Reference Type RESULT

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IVF-2020

Identifier Type: -

Identifier Source: org_study_id