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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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

Detailed Summary:
Sponsor: IVFarma LLC

Current Primary Outcome: Number of oocytes retrieved [ Time Frame: From date of randomization up to 18 days ]

The total number of retrieved oocytes at the day of ovum pick-up


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number and size of follicles ≥ 16 mm [ Time Frame: From date of randomization up to 16 days ]
    The number and size of follicles 16 mm or over in diameter at day of hCG administration
  • Quality of oocytes [ Time Frame: From date of randomization up to 18 days ]
    Mature oocytes (MII stage of development)
  • Fertilisation rate [ Time Frame: From date of randomization up to 19 days ]
    Fertilisation rate (presence of two pronuclei:2PN)
  • Number of patients with embryo transfer [ Time Frame: From date of randomization up to 25 days ]
    Embryo transfer rate (Days 2-5 after ovum pick-up)
  • Total dose of follitropin alfa [ Time Frame: From date of randomization up to 16 days ]
    Mean dose of follitropin alfa for ovarian hyperstimulation
  • Number of days of follitropin alfa treatment [ Time Frame: From date of randomization up to 16 days ]
    Mean duration of ovarian hyperstimulation (at the day of hCG administration)
  • Number of patients with follitropin alfa dose correction [ Time Frame: From date of randomization up to 16 days ]
    Mean number of dose adjustments (increment 25-50 IU)
  • Number of patients with cycle cancellation [ Time Frame: From date of randomization up to 16 days ]
    Mean cancellation rate during ovarian hyperstimulation (at the day of hCG administration)
  • Number of no-responders [ Time Frame: From date of randomization up to 8 days ]
    Number of patients with no response to follitropin alfa treatment
  • Biochemical pregnancy rate [ Time Frame: From date of randomization up to 42 days ]
    Serum hCG more than 25 IU/l (days 12-17 after embryo transfer)
  • Clinical pregnancy rate [ Time Frame: From date of randomization up to 14 weeks ]
    Presence of at least one intrauterine gestational sac


Original Secondary Outcome: Same as current

Information By: IVFarma LLC

Dates:
Date Received: March 2, 2017
Date Started: February 8, 2017
Date Completion: May 1, 2018
Last Updated: March 22, 2017
Last Verified: March 2017