Trial · Observational

CompletedPhase not statedResults postedRegistry data

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

NCTNCT04854707Other idIVF-2020

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names Cetrorelix, does not test it. It appears in the description.
Names Ganirelix, does not test it. It appears in the description.
Names Triptorelin (Trelstar, Decapeptyl), does not test it. It appears in the description.

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 5,484 participants (actual)
Sponsor: IVFarma LLC · Industry
Design: Not stated
Countries: 1 country
Russia
Start: 12 Jan 2020
Primary completion: 20 Dec 2020
Completion: 20 Jan 2021
First posted: 22 Apr 2021
Last update posted: 22 Oct 2021
Conditions: Reproductive Issues · Reproductive Disorder · Fertility Disorders · Fertility Issues · Gynecologic Disease · IVF

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022

Ph –
An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
NCT04854707
12 Jan 2020 to 20 Jan 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Follitropin AlfaDrug
Follicle Stimulating Hormone/Luteinizing HormoneDrug
Follitropin AlfaDrug
Follitropin AlfaDrug
Follicle Stimulating Hormone/Luteinizing HormoneDrug

Arms5

Other
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.
Other
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.
Other
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.
Other
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.
Other
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

Primary outcomes2

Outcomes the sponsor listed as primary.

Number of Oocytes Retrieved
Time frame · From date of start of ovarian stimulation with follitropin alpha up to 15 days
Registry description
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).
Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer
Time frame · At least 6 weeks after embryo transfer
Registry description
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).

Secondary outcomes(3)

Number of Mature Oocytes
Time frame · From date of start of ovarian stimulation with follitropin alpha up to 15 days
Registry description
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).
Number of Fertilized Oocytes
Time frame · From date of start of ovarian stimulation with follitropin alpha up to 16 days
Registry description
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).
Total Dose of Follitropin Alpha Biosimilar Protocol, IU
Time frame · From date of start of ovarian stimulation with follitropin alpha up to 16 days
Registry description
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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· From date of start of ovarian stimulation with follitropin alpha up to 15 days

Number of Oocytes Retrieved

Group	Value (The total number of retrieved oocytes)	Spread
Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH	8.6	6.8
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH	10.3	7.4
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH	10.5	7.5
Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH	9.6	7.0
The Overall Protocols	9.5	7.2

Primary outcomeNumber· At least 6 weeks after embryo transfer

Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer

Group	Value (Percetnage of patients (%))
Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH	39.3
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH	37.6
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH	37.9
Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH	35.9
The Overall Protocols	38.4

Secondary and other outcome results(3)

Secondary outcomeMean· From date of start of ovarian stimulation with follitropin alpha up to 15 days

Number of Mature Oocytes

Group	Value (Number of mature oocytes)	Spread
Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH	6.7	6.2
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH	7.7	6.9
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH	7.6	6.9
Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH	6.7	5.7
The Overall Protocols	6.8	6.6

Secondary outcomeMean· From date of start of ovarian stimulation with follitropin alpha up to 16 days

Number of Fertilized Oocytes

Group	Value (zygotes with 2PN)	Spread
Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH	5.8	5.2
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH	7.2	6.2
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH	7.3	6.3
Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH	5.7	5.0
The Overall Protocols	6.1	5.8

Secondary outcomeMean· From date of start of ovarian stimulation with follitropin alpha up to 16 days

Total Dose of Follitropin Alpha Biosimilar Protocol, IU

Group	Value (IU (International Units))	Spread
Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH	1672	568
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH	1919	639
Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH	1952	621
Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH	1711	680
The Overall Protocols	1825	647

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
The Overall ProtocolsThe overall protocols (groups) were combined and analysed for Serious Adverse Events and other (not including serious) adverse events. Due to overall ovarian stimulation protocols consist of follitropin alpha biosimilar treatment for at least 5 days, the adverse events were combined in one group to analyse the safety of follitropin alpha biosimilar treatment not in relation to protocol of ovarian stimulation and other medication.	0 / 5484	0 / 5484	657 / 5484

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultM 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
ResultKamilova 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

Eligibility

Who could join, as posted.

Sex: Female
Age: from 20 Years up to 43 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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