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 ]
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