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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 : Recruiting
First Posted : March 23, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
BridgePharm 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : May 1, 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. 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


Secondary Outcome Measures :
  1. 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

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

  3. Fertilisation rate [ Time Frame: From date of randomization up to 19 days ]
    Fertilisation rate (presence of two pronuclei:2PN)

  4. 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)

  5. Total dose of follitropin alfa [ Time Frame: From date of randomization up to 16 days ]
    Mean dose of follitropin alfa for ovarian hyperstimulation

  6. 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)

  7. 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)

  8. 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)

  9. Number of no-responders [ Time Frame: From date of randomization up to 8 days ]
    Number of patients with no response to follitropin alfa treatment

  10. 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)

  11. Clinical pregnancy rate [ Time Frame: From date of randomization up to 14 weeks ]
    Presence of at least one intrauterine gestational sac



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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 ≥ 18 ≤ 30 kg/m2
  • Basal FSH < 10 IU/L (cycle day 2-5)
  • E2 levels < 50pg/mL (cycle day 2)
  • AMH ≥ 1.0 ng/ml
  • Antral follicle count (AFC) ≥ 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 cycles (IVF and/or ICSI) 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 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/TESE/TESA
  • Smoking > 10 cigarettes/day
  • Narcomania, alcoholism
  • Planned PGS/PGD

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
Russian Federation
Clinical Hospital Lapino Recruiting
Moscow Oblast, Russian Federation
Contact: Raisa Shalina, D.Sc.    +7 (495) 526-60-60    lpn.info@mcclinics.ru   
AltraVita IVF clinic Recruiting
Moscow, Russian Federation
Contact: Tatyana Teterina, PhD    +7 (499) 969-81-58    info@altravita-ivf.ru   
Perinatal Medical Center Recruiting
Moscow, Russian Federation
Contact: Lali Sichinava, D.Sc.    +7 (495) 331-85-10    info@mospmc.ru   
Sponsors and Collaborators
IVFarma LLC
BridgePharm LLC

Responsible Party: IVFarma LLC
ClinicalTrials.gov Identifier: NCT03088137     History of Changes
Other Study ID Numbers: FSG-03-01
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs