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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04854707
Other study ID # IVF-2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 12, 2020
Est. completion date January 20, 2021

Study information

Verified date September 2021
Source IVFarma LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 5484
Est. completion date January 20, 2021
Est. primary completion date December 20, 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 43 Years
Eligibility 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 Design


Intervention

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.
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.
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.
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.
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).

Locations

Country Name City State
Russian Federation Center for reproductive medicine, Barnaul Barnaul
Russian Federation Clinical Institute of Reproductive Medicine Ekaterinburg
Russian Federation Center for reproductive medicine, Irkutsk Irkutsk
Russian Federation Clinic "Mother and Child" Kazan Kazan
Russian Federation Clinic "Mother and Child" Kostroma Kostroma
Russian Federation Clinic "Mother and Child" Krasnodar Krasnodar
Russian Federation Center for reproductive medicine, Krasnoyarsk Krasnoyarsk
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
Russian Federation Clinical Hospital Lapino Moscow Oblast
Russian Federation Clinic "Mother and Child" Nizhny Novgorod
Russian Federation Medika-2 Novokuznetsk
Russian Federation Center for reproductive medicine, Novosibirsk Novosibirsk
Russian Federation Clinical Hospital "Avicenna" Novosibirsk
Russian Federation Ceter for reproductive medicine, Omsk Omsk
Russian Federation Clinic "Mother and Child" Perm Perm
Russian Federation Clinic "Mother and Child" Rostov-on-Don Rostov-on-Don
Russian Federation Clinic "Mather and Child" Ryazan'
Russian Federation "Genesis" Reproduction Centre Saint Petersburg
Russian Federation Clinic "Mother and Child" Saint-Petersburg Saint Petersburg
Russian Federation Clinical Hospital "Mother and Child" Samara
Russian Federation Clinic "Mather and Child" Tula Tula
Russian Federation Clinical Hospital "Mother and Child" Tyumen
Russian Federation Clinical Hospital "Mother and Child" Ufa
Russian Federation Clinic "Mother and Child" Vladimir Vladimir
Russian Federation Clinic "Mather and Child" Vladivostok Vladivostok
Russian Federation Clinic "Mother and Child" Volgograd Volgograd
Russian Federation Clinic "Mother and Child" Voronezh Voronezh
Russian Federation Clinic "Mother and Child" Yaroslavl Yaroslavl

Sponsors (2)

Lead Sponsor Collaborator
IVFarma LLC Institute for Preventive and Social Medicine

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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., T

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
From date of start of ovarian stimulation with follitropin alpha up to 15 days
Primary 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).
At least 6 weeks after embryo transfer
Secondary 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).
From date of start of ovarian stimulation with follitropin alpha up to 15 days
Secondary 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).
From date of start of ovarian stimulation with follitropin alpha up to 16 days
Secondary 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).
From date of start of ovarian stimulation with follitropin alpha up to 16 days
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