CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,484 enrolled
Drug / intervention
Follitropin Alfa +4 moredrug
Likely dose
Follitropin Alfa 300 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04854707
NCT04854707N/ACompleted
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An Observational Study "FOLLITROPIN" Comparing the Efficacy of Follitropin Alpha Biosimilar: the Real-world Data

IVFarma LLC·observational·Posted Apr 22, 2021·Updated Oct 22, 2021

In Brief

An observational study evaluating Follitropin Alfa and Follicle Stimulating Hormone/Luteinizing Hormone for Reproductive Issues and 5 related conditions. Completed, enrolled 5,484 participants across 35 sites.

Detailed Summary

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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsReproductive Issues, Reproductive Disorder, Fertility Disorders, Fertility Issues, Gynecologic Disease, IVF
CountriesRussia
CollaboratorsInstitute for Preventive and Social Medicine

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 22, 2021
Enrollment StartJan 12, 2020
Primary CompletionDec 20, 2020
Study CompletionJan 20, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.2 years ago

Interventions

Follitropin Alfadrug

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 Hormonedrug

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 Alfadrug

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 Alfadrug

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 Hormonedrug

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).