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Reproductive IssuesNCT04854707

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

An observational study of Reproductive Issues and Reproductive Disorder, run by IVFarma LLC at 35 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 43 years, women only
What is being tested?
Follitropin Alfa and Follicle Stimulating Hormone/Luteinizing Hormone
Type of treatment
Injection or infusion
How many people
5,484 participants
Where
35 sitesRussia
Study dates
12 Jan 2020to 20 Jan 2021
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 43 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
  • Neoplasia
  • Narcomania, alcoholism

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

Russia35 sites

  • Center for reproductive medicine, Barnaul

    Barnaul

  • Center for reproductive medicine, Irkutsk

    Irkutsk

  • Clinic "Mother and Child" Kazan

    Kazan'

  • Clinic "Mother and Child" Kostroma

    Kostroma

  • Clinic "Mother and Child" Krasnodar

    Krasnodar

  • Center for reproductive medicine, Krasnoyarsk

    Krasnoyarsk

  • AltraVita IVF clinic

    Moscow

  • Center of Reproductive Medicine and Genetics "Nova Clinic"

    Moscow

  • Clinic "Mather and Child" Lefortovo

    Moscow

  • Clinic "Mather and Child" Savelovskaya

    Moscow

  • Clinic "Mother and Child" Khodynskoe Pole

    Moscow

  • Clinic "Mother and Child" Kuntsevo

    Moscow

  • Clinic "Mother and Child" South-West

    Moscow

  • Clinical Hospital MD GROUP (Perinatal Center on Sevastopolskiy)

    Moscow

  • Clinical Hospital Lapino

    Moscow Oblast

  • Clinic "Mother and Child"

    Nizhny Novgorod

  • Medika-2

    Novokuznetsk

  • Center for reproductive medicine, Novosibirsk

    Novosibirsk

  • Clinical Hospital "Avicenna"

    Novosibirsk

  • Ceter for reproductive medicine, Omsk

    Omsk

  • Clinic "Mother and Child" Perm

    Perm

  • Clinic "Mother and Child" Rostov-on-Don

    Rostov-on-Don

  • Clinic "Mather and Child"

    Ryazan

  • "Genesis" Reproduction Centre

    Saint Petersburg

  • Clinic "Mother and Child" Saint-Petersburg

    Saint Petersburg

  • Clinical Hospital "Mother and Child"

    Samara

  • Clinic "Mather and Child" Tula

    Tula

  • Clinical Hospital "Mother and Child"

    Tyumen

  • Clinical Hospital "Mother and Child"

    Ufa

  • Clinic "Mother and Child" Vladimir

    Vladimir

  • Clinic "Mather and Child" Vladivostok

    Vladivostok

  • Clinic "Mother and Child" Volgograd

    Volgograd

  • Clinic "Mother and Child" Voronezh

    Voronezh

  • Clinic "Mother and Child" Yaroslavl

    Yaroslavl

  • Clinical Institute of Reproductive Medicine

    Yekaterinburg

Other trials in Russia

About this study

Official title: 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.

Read the 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.

Being tested
Follitropin Alfa, Follicle Stimulating Hormone/Luteinizing Hormone
Keywords
follitropin alpha, follicle-stimulating hormone, in vitro fertilization, assisted reproductive technologies, biosimilar, follitropin alfa, real-world data
Medical subject headings
Infertility, Genital Diseases, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Follitropin AlfaDrug

    Also called Primapur, Biosimilar

    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.

  • Follicle Stimulating Hormone/Luteinizing HormoneDrug

    Also called Follitropin beta, Follitropin alfa + Lutropin alfa, Corifollitropin alfa, Menotropins

    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.

  • Follitropin AlfaDrug

    Also called Primapur, Biosimilar, Follitropin alfa biosimilar

    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.

  • Follitropin AlfaDrug

    Also called Primapur, Biosimilar, Follitropin alfa biosimilar

    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.

  • Follicle Stimulating Hormone/Luteinizing HormoneDrug

    Also called Follitropin beta, Corifollitropin alfa, Follitropin alfa + Lutropin alfa, Menotropins

    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).

Study groups in NCT04854707
Study groupRoleWhat they receive
Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRHThe 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.
Receives: Drug: Follitropin Alfa
Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRHThe 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.
Receives: Drug: Follicle Stimulating Hormone/Luteinizing Hormone
Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRHThe OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH.
Receives: Drug: Follitropin Alfa
Monoprotocols: follitropin alpha biosimilar only and agonist of GnRHThe OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH.
Receives: Drug: Follitropin Alfa
The overall protocolsThe 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
Receives: Drug: Follicle Stimulating Hormone/Luteinizing Hormone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Oocytes Retrieved

    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).

    Measured: From date of start of ovarian stimulation with follitropin alpha up to 15 days

  2. Percentage of Participants With Ongoing Clinical Pregnancy Per 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).

    Measured: At least 6 weeks after embryo transfer

Secondary outcomes (3)

  1. Number of Mature Oocytes

    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).

    Measured: From date of start of ovarian stimulation with follitropin alpha up to 15 days

  2. Number of Fertilized Oocytes

    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).

    Measured: From date of start of ovarian stimulation with follitropin alpha up to 16 days

  3. Total Dose of Follitropin Alpha Biosimilar Protocol, IU

    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).

    Measured: From date of start of ovarian stimulation with follitropin alpha up to 16 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2021
  2. Study start12 Jan 2020
  3. Primary completion20 Dec 2020
  4. Study completion20 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
5,484 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04854707
Sponsor's protocol ID
IVF-2020
Status last verified
Sep 2021
First submitted
18 Apr 2021
Last updated
22 Oct 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Reproductive Issues and Reproductive Disorder, run by IVFarma LLC at 35 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Oocytes Retrieved (time frame: From date of start of ovarian stimulation with follitropin alpha up to 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04854707, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.

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