Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03088137
Recruitment Status : Completed
First Posted : March 23, 2017
Results First Posted : June 6, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
BridgePharm LLC
GlobalPharma LLC
Information provided by (Responsible Party):
IVFarma LLC

Tracking Information
First Submitted Date  ICMJE March 2, 2017
First Posted Date  ICMJE March 23, 2017
Results First Submitted Date  ICMJE October 13, 2018
Results First Posted Date  ICMJE June 6, 2019
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE February 8, 2017
Actual Primary Completion Date August 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
Oocytes (Intention-to-Treat, ITT) [ Time Frame: From date of randomization up to 18 days ]
The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes.
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2019)
  • Number of Follicles With Size ≥ 16 mm [ Time Frame: From date of randomization up to 16 days ]
    The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration
  • Mature Oocytes [ Time Frame: From date of randomization up to 18 days ]
    The number of mature oocytes (MII stage of development)
  • Fertilised Oocytes [ Time Frame: From date of randomization up to 19 days ]
    The number of fertilised oocytes with the presence of two pronuclei: 2PN
  • Percentage of Patients With Embryo Transfer [ Time Frame: From date of randomization up to 25 days ]
    The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up
  • Total Dose of Follitropin Alfa [ Time Frame: From date of randomization up to 16 days ]
    The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU)
  • Number of Days of Follitropin Alfa Treatment [ Time Frame: From date of randomization up to 16 days ]
    The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation)
  • Number of Patients With Follitropin Alfa Dose Correction [ Time Frame: From date of randomization up to 16 days ]
    The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU)
  • Number of Patients With Cycle Cancellation [ Time Frame: From date of randomization up to 16 days ]
    The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation)
  • Number of No-responders [ Time Frame: From date of randomization up to 8 days ]
    The number of patients with no response to follitropin alfa treatment (absence of growing follicles, no any oocytes obtained at the day of ovum pick-up)
  • Percentage of Patients With Serum hCG More Than 25 IU/l [ Time Frame: From date of randomization up to 42 days ]
    Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer)
  • Percentage of Patients With the Evidence for Clinical Pregnancy [ Time Frame: The 10th week after embryo transfer ]
    Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infertility, Female
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Primapur (Follitropin alfa)
    Intervention: Drug: Follitropin alfa (Primapur)
  • Active Comparator: Gonal-f (Follitropin alfa)
    Intervention: Drug: Follitropin alfa (Gonal-f)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2018)
118
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2017)
140
Actual Study Completion Date  ICMJE August 17, 2018
Actual Primary Completion Date August 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infertility due to tubal factor and/or male factor
  • Age between 20 and 35 years with regular menstrual cycles of 21-35 days
  • First or second cycle in the present series of ART
  • BMI (body mass index) ≥ 18 ≤ 30 kg/m2
  • Basal FSH (follicle stimulating hormone) < 10 IU/L (cycle day 2-5)
  • E2 (estradiol) levels < 50pg/mL (cycle day 2)
  • AMH (anti-mullerian hormone) ≥ 1.0 ng/ml
  • Antral follicle ≥ 4 to ≤ 15 follicles (both ovaries)
  • Presence of both ovaries and normal uterine cavity
  • Informed consent

Exclusion Criteria:

  • Presence of pregnancy
  • Hypersensitivity to follitropin alfa
  • Ovarian cysts
  • History of ≥2 succeeding ART (assisted reproductive technology) cycles IVF (in vitro fertilization) and/or ICSI (Intracytoplasmic sperm injection) before the study cycle
  • Previous history of severe ovarian hyperstimulation syndrome
  • Presence of polycystic ovaries (PCO)
  • Presence of endometriosis and hydrosalpinx
  • Presence of uterine disorders
  • History of poor (< 4 oocytes) or hyper (> 25 oocytes) responses to FSH treatment at dose 150 IU and GnRH-antagonist (gonadotropin-releasing hormone) protocol
  • Premature ovarian failure
  • Ectopic pregnancy (3 month before the study cycle)
  • Presence of clinically significant systemic disease
  • Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
  • Presence of endocrine disorder
  • Neoplasia
  • Male infertility without mobile spermatozoa in the ejaculate, that need MESA (Microsurgical epididymal sperm aspiration)/TESE (testicular sperm extraction)/TESA (testicular sperm aspiration)
  • Smoking > 10 cigarettes/day
  • Narcomania, alcoholism
  • Planned PGS (preimplantation genetic screeneing) /PGD (preimplantation genetic diagnosis)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03088137
Other Study ID Numbers  ICMJE FSG-03-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party IVFarma LLC
Study Sponsor  ICMJE IVFarma LLC
Collaborators  ICMJE
  • BridgePharm LLC
  • GlobalPharma LLC
Investigators  ICMJE Not Provided
PRS Account IVFarma LLC
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP