Status:
COMPLETED
An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
Lead Sponsor:
IVFarma LLC
Collaborating Sponsors:
Institute for Preventive and Social Medicine
Conditions:
Reproductive Issues
Reproductive Disorder
Eligibility:
FEMALE
20-43 years
Brief Summary
Aim to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.
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 saf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 20 2021
Estimated Enrollment :
5484 Patients enrolled
Trial Details
Trial ID
NCT04854707
Start Date
January 12 2020
End Date
January 20 2021
Last Update
October 22 2021
Active Locations (35)
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1
Center for reproductive medicine, Barnaul
Barnaul, Russia
2
Center for reproductive medicine, Irkutsk
Irkutsk, Russia
3
Clinic "Mother and Child" Kazan
Kazan', Russia
4
Clinic "Mother and Child" Kostroma
Kostroma, Russia