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

September 24, 2021 updated by: IVFarma LLC

An Observational Study "FOLLITROPIN" Comparing the Efficacy of Follitropin Alpha Biosimilar: the Real-world Data

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

5484

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Barnaul, Russian Federation
        • Center for reproductive medicine, Barnaul
      • Ekaterinburg, Russian Federation
        • Clinical Institute of Reproductive Medicine
      • Irkutsk, Russian Federation
        • Center for reproductive medicine, Irkutsk
      • Kazan, Russian Federation
        • Clinic "Mother and Child" Kazan
      • Kostroma, Russian Federation
        • Clinic "Mother and Child" Kostroma
      • Krasnodar, Russian Federation
        • Clinic "Mother and Child" Krasnodar
      • Krasnoyarsk, Russian Federation
        • Center for reproductive medicine, Krasnoyarsk
      • Moscow, Russian Federation
        • AltraVita IVF clinic
      • Moscow, Russian Federation
        • Center of Reproductive Medicine and Genetics "Nova Clinic"
      • Moscow, Russian Federation
        • Clinic "Mather and Child" Lefortovo
      • Moscow, Russian Federation
        • Clinic "Mather and Child" Savelovskaya
      • Moscow, Russian Federation
        • Clinic "Mother and Child" Khodynskoe Pole
      • Moscow, Russian Federation
        • Clinic "Mother and Child" Kuntsevo
      • Moscow, Russian Federation
        • Clinic "Mother and Child" South-West
      • Moscow, Russian Federation
        • Clinical Hospital MD GROUP (Perinatal Center on Sevastopolskiy)
      • Moscow Oblast, Russian Federation
        • Clinical Hospital Lapino
      • Nizhny Novgorod, Russian Federation
        • Clinic "Mother and Child"
      • Novokuznetsk, Russian Federation
        • Medika-2
      • Novosibirsk, Russian Federation
        • Center for reproductive medicine, Novosibirsk
      • Novosibirsk, Russian Federation
        • Clinical Hospital "Avicenna"
      • Omsk, Russian Federation
        • Ceter for reproductive medicine, Omsk
      • Perm, Russian Federation
        • Clinic "Mother and Child" Perm
      • Rostov-on-Don, Russian Federation
        • Clinic "Mother and Child" Rostov-on-Don
      • Ryazan', Russian Federation
        • Clinic "Mather and Child"
      • Saint Petersburg, Russian Federation
        • "Genesis" Reproduction Centre
      • Saint Petersburg, Russian Federation
        • Clinic "Mother and Child" Saint-Petersburg
      • Samara, Russian Federation
        • Clinical Hospital "Mother and Child"
      • Tula, Russian Federation
        • Clinic "Mather and Child" Tula
      • Tyumen, Russian Federation
        • Clinical Hospital "Mother and Child"
      • Ufa, Russian Federation
        • Clinical Hospital "Mother and Child"
      • Vladimir, Russian Federation
        • Clinic "Mother and Child" Vladimir
      • Vladivostok, Russian Federation
        • Clinic "Mather and Child" Vladivostok
      • Volgograd, Russian Federation
        • Clinic "Mother and Child" Volgograd
      • Voronezh, Russian Federation
        • Clinic "Mother and Child" Voronezh
      • Yaroslavl, Russian Federation
        • Clinic "Mother and Child" Yaroslavl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 43 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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 or agonist of GnRH.
Other Names:
  • Primapur
  • Biosimilar
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.
Other Names:
  • Primapur
  • Biosimilar
  • Follitropin alfa biosimilar
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.
Other Names:
  • Primapur
  • Biosimilar
  • Follitropin alfa biosimilar
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.
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.
Other Names:
  • Follitropin alfa
  • Corifollitropin alfa
  • Follitropin beta
  • Follitropin alfa + Lutropin alfa
  • Menotropins
  • Follitropin alfa biosimilar
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).
Other Names:
  • Follitropin alfa
  • Corifollitropin alfa
  • Follitropin beta
  • Follitropin alfa + Lutropin alfa
  • Menotropins
  • Follitropin alfa biosimilar
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.
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 or agonist of GnRH.
Other Names:
  • Primapur
  • Biosimilar
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.
Other Names:
  • Primapur
  • Biosimilar
  • Follitropin alfa biosimilar
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.
Other Names:
  • Primapur
  • Biosimilar
  • Follitropin alfa biosimilar
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.
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 or agonist of GnRH.
Other Names:
  • Primapur
  • Biosimilar
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.
Other Names:
  • Primapur
  • Biosimilar
  • Follitropin alfa biosimilar
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.
Other Names:
  • Primapur
  • Biosimilar
  • Follitropin alfa biosimilar
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
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.
Other Names:
  • Follitropin alfa
  • Corifollitropin alfa
  • Follitropin beta
  • Follitropin alfa + Lutropin alfa
  • Menotropins
  • Follitropin alfa biosimilar
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).
Other Names:
  • Follitropin alfa
  • Corifollitropin alfa
  • Follitropin beta
  • Follitropin alfa + Lutropin alfa
  • Menotropins
  • Follitropin alfa biosimilar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Oocytes Retrieved
Time Frame: From date of start of ovarian stimulation with follitropin alpha up to 15 days

The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the ovulation inducer (HCG or GnRH-agonist).

Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646).
From date of start of ovarian stimulation with follitropin alpha up to 15 days
Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer
Time Frame: At least 6 weeks after embryo transfer

Ongoing clinical pregnancy per embryo transfer (detection of gestational sac and heartbeat from 6 weeks after transfer), n (ongoing pregnancy rate per transfer with known outcome, %).

Due to delayed embryo transfers, the analysed population for "Ongoing clinical pregnancy per embryo transfer" was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2007 embryo transfers (1542 with known outcome); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2213 embryo transfers (1800 with known outcome); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 1809 embryo transfers (1466 with known outcome) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 404 embryo transfers (334 with known outcome).
At least 6 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Mature Oocytes
Time Frame: From date of start of ovarian stimulation with follitropin alpha up to 15 days

Mature oocytes (MII stage of development).

Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646).
From date of start of ovarian stimulation with follitropin alpha up to 15 days
Number of Fertilized Oocytes
Time Frame: From date of start of ovarian stimulation with follitropin alpha up to 16 days

Fertilization rate (FR) is percentage of transformation of oocytes into two pronuclei (presence of two pronuclei: zygotes with 2PN).

Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646).
From date of start of ovarian stimulation with follitropin alpha up to 16 days
Total Dose of Follitropin Alpha Biosimilar Protocol, IU
Time Frame: From date of start of ovarian stimulation with follitropin alpha up to 16 days

Mean dose of follitropin alpha biosimilar for ovarian stimulation.

Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646).
From date of start of ovarian stimulation with follitropin alpha up to 16 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVFarma LLC

Collaborators

Institute for Preventive and Social Medicine

Investigators

  • Principal Investigator: Dilorom Kamilova, PhD, MD Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 12, 2020

Primary Completion (ACTUAL)

December 20, 2020

Study Completion (ACTUAL)

January 20, 2021

Study Registration Dates

First Submitted

April 18, 2021

First Submitted That Met QC Criteria

April 18, 2021

First Posted (ACTUAL)

April 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVF-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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