Skip to main content
OpenTrials
Completed

NCT Number: NCT03088137

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

AltraVita IVF clinic, Moscow, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Follitropin Alfa (GONAL-F)

Drug

Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

Follitropin alfa (Primapur)

Drug

Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

IVFarma LLC

Industry

Collaborators

  • BridgePharm LLC
  • GlobalPharma LLC

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 23, 2017
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.