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

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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

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

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: Follitropin alfa (Gonal-f) Drug: Follitropin alfa (Primapur) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Actual Study Start Date : February 8, 2017
Actual Primary Completion Date : August 17, 2018
Actual Study Completion Date : August 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Primapur (Follitropin alfa) Drug: Follitropin alfa (Primapur)
Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

Active Comparator: Gonal-f (Follitropin alfa) Drug: Follitropin alfa (Gonal-f)
Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Mature Oocytes [ Time Frame: From date of randomization up to 18 days ]
    The number of mature oocytes (MII stage of development)

  3. Fertilised Oocytes [ Time Frame: From date of randomization up to 19 days ]
    The number of fertilised oocytes with the presence of two pronuclei: 2PN

  4. 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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088137


Locations
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Russian Federation
Clinical Hospital Lapino
Moscow Oblast, Russian Federation
AltraVita IVF clinic
Moscow, Russian Federation
Perinatal Medical Center
Moscow, Russian Federation
Sponsors and Collaborators
IVFarma LLC
BridgePharm LLC
GlobalPharma LLC
  Study Documents (Full-Text)

Documents provided by IVFarma LLC:
Additional Information:
Publications of Results:
M. Polzikov, Z. Barakhoeva, S. Yakovenko, M. Ovchinnikova, L.Vovk, Y. Fetisova. A multicenter, randomized study comparing the efficacy of follitropin alpha biosimilar and the original follitropin alpha. Abstracts of the 35th Annual Meeting of the ESHRE, Vienna, Austria 24 to 26 June 2019 (abstract P-649), Human Reproduction, 2019; Vol. 34, Suppl. 1, p. i439.

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Responsible Party: IVFarma LLC
ClinicalTrials.gov Identifier: NCT03088137    
Other Study ID Numbers: FSG-03-01
First Posted: March 23, 2017    Key Record Dates
Results First Posted: June 6, 2019
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IVFarma LLC:
in vitro fertilization
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs