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

IVFarma

Status: Completed

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

Treatments: Drug: Follitropin Alfa; Drug: Follicle Stimulating Hormone/Luteinizing Hormone

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04854707

IVF-2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,484 patients

Sex: Female

Ages: 20 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

5,484 participants in 5 patient groups

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

Description:

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.

Treatment:

Drug: Follitropin Alfa

Drug: Follitropin Alfa

Drug: Follitropin Alfa

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

Description:

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.

Treatment:

Drug: Follicle Stimulating Hormone/Luteinizing Hormone

Drug: Follicle Stimulating Hormone/Luteinizing Hormone

Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH

Description:

The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH.

Treatment:

Drug: Follitropin Alfa

Drug: Follitropin Alfa

Drug: Follitropin Alfa

Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH

Description:

The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH.

Treatment:

Drug: Follitropin Alfa

Drug: Follitropin Alfa

Drug: Follitropin Alfa

The overall protocols

Description:

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

Treatment:

Drug: Follicle Stimulating Hormone/Luteinizing Hormone

Drug: Follicle Stimulating Hormone/Luteinizing Hormone