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

NCT04854707 | Completed Results

• 1 other identifier: IVF-2020
• Study Type: observational
• Target: 5,484
• Locations: 1 country
• Sites: 35

Brief Summary

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

Conditions

Reproductive Issues; Reproductive Disorder; Fertility Disorders; Fertility Issues; Gynecologic Disease; IVF

Keywords

follitropin alpha; follicle-stimulating hormone; in vitro fertilization; assisted reproductive technologies; biosimilar; follitropin alfa; real-world data

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Number of Mature Oocytes

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

• Number of Fertilized Oocytes

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

• Total Dose of Follitropin Alpha Biosimilar Protocol, IU

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

Study Arms (5)

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

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

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

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

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

Interventions

Follitropin Alfa 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.

Also known as: Primapur, Biosimilar

Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH

Follicle Stimulating Hormone/Luteinizing Hormone 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.

Also known as: Follitropin beta, Follitropin alfa + Lutropin alfa, Corifollitropin alfa, Menotropins, Follitropin alfa, Follitropin alfa biosimilar

Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH

Eligibility Criteria

• Age: 20 Years - 43 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IVFarma LLC: lead
• Institute for Preventive and Social Medicine: collaborator

Study Sites (35)

Center for reproductive medicine, Barnaul

Barnaul, Russia

Location

Center for reproductive medicine, Irkutsk

Irkutsk, Russia

Location

Clinic "Mother and Child" Kazan

Kazan', Russia

Location

Clinic "Mother and Child" Kostroma

Kostroma, Russia

Location

Clinic "Mother and Child" Krasnodar

Krasnodar, Russia

Location

Center for reproductive medicine, Krasnoyarsk

Krasnoyarsk, Russia

Location

AltraVita IVF clinic

Moscow, Russia

Location

Center of Reproductive Medicine and Genetics "Nova Clinic"

Moscow, Russia

Location

Clinic "Mather and Child" Lefortovo

Moscow, Russia

Location

Clinic "Mather and Child" Savelovskaya

Moscow, Russia

Location

Clinic "Mother and Child" Khodynskoe Pole

Moscow, Russia

Location

Clinic "Mother and Child" Kuntsevo

Moscow, Russia

Location

Clinic "Mother and Child" South-West

Moscow, Russia

Location

Clinical Hospital MD GROUP (Perinatal Center on Sevastopolskiy)

Moscow, Russia

Location

Clinical Hospital Lapino

Moscow Oblast, Russia

Location

Clinic "Mother and Child"

Nizhny Novgorod, Russia

Location

Medika-2

Novokuznetsk, Russia

Location

Center for reproductive medicine, Novosibirsk

Novosibirsk, Russia

Location

Clinical Hospital "Avicenna"

Novosibirsk, Russia

Location

Ceter for reproductive medicine, Omsk

Omsk, Russia

Location

Clinic "Mother and Child" Perm

Perm, Russia

Location

Clinic "Mother and Child" Rostov-on-Don

Rostov-on-Don, Russia

Location

Clinic "Mather and Child"

Ryazan, Russia

Location

"Genesis" Reproduction Centre

Saint Petersburg, Russia

Location

Clinic "Mother and Child" Saint-Petersburg

Saint Petersburg, Russia

Location

Clinical Hospital "Mother and Child"

Samara, Russia

Location

Clinic "Mather and Child" Tula

Tula, Russia

Location

Clinical Hospital "Mother and Child"

Tyumen, Russia

Location

Clinical Hospital "Mother and Child"

Ufa, Russia

Location

Clinic "Mother and Child" Vladimir

Vladimir, Russia

Location

Clinic "Mather and Child" Vladivostok

Vladivostok, Russia

Location

Clinic "Mother and Child" Volgograd

Volgograd, Russia

Location

Clinic "Mother and Child" Voronezh

Voronezh, Russia

Location

Clinic "Mother and Child" Yaroslavl

Yaroslavl, Russia

Location

Clinical Institute of Reproductive Medicine

Yekaterinburg, Russia

Location

Related Publications (2)

• 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

  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

  RESULT

MeSH Terms

Conditions

Infertility; Genital Diseases, Female

Interventions

follitropin alfa; Biosimilar Pharmaceuticals; Menotropins; follitropin beta; Luteinizing Hormone, beta Subunit; follicle stimulating hormone, human, with HCG C-terminal peptide

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Luteinizing Hormone

Limitations and Caveats

The real-world patient data analysed in this study were representative, showing the ability of follitropin biosimilars to develop both folliculogenesis and clinical pregnancy in a nonselected population. Additional comparative studies are needed to confirm the efficacy of the biosimilars in patients with classified types of infertility causes, including unexplained infertility.

Results Point of Contact

• Title: General Manager
• Organization: IVFarma LLC

info@ivfarma.ru

+74996455342

Study Officials

• Dilorom Kamilova, PhD

  MD Medical Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 22, 2021
• Study Start: January 12, 2020
• Primary Completion: December 20, 2020
• Study Completion: January 20, 2021
• Last Updated: October 22, 2021
• Results First Posted: October 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (35)