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Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

NCT03088137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2022-04-01

Study results available
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Summary

The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI

Conditions

  • Infertility, Female

Interventions

DRUG

Follitropin alfa (Gonal-f)

Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

DRUG

Follitropin alfa (Primapur)

Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

Sponsors & Collaborators

  • BridgePharm LLC

    collaborator UNKNOWN

  • GlobalPharma LLC

    collaborator UNKNOWN

  • IVFarma LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2018-08-17
Completion
2018-08-17

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 NCT03088137 on ClinicalTrials.gov