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

NCT04854707 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5484

Last updated 2021-10-22

Study results available
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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

Interventions

DRUG

Follitropin Alfa

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.

DRUG

Follicle Stimulating Hormone/Luteinizing Hormone

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.

DRUG

Follitropin Alfa

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.

DRUG

Follitropin Alfa

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.

DRUG

Follicle Stimulating Hormone/Luteinizing Hormone

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).

Sponsors & Collaborators

  • Institute for Preventive and Social Medicine

    collaborator OTHER

  • IVFarma LLC

    lead INDUSTRY

Principal Investigators

  • Dilorom Kamilova, PhD · MD Medical Group

Eligibility

Min Age
20 Years
Max Age
43 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-12
Primary Completion
2020-12-20
Completion
2021-01-20

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04854707 on ClinicalTrials.gov