NCT03088137

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2018

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 6, 2019

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

March 2, 2017

Results QC Date

October 13, 2018

Last Update Submit

March 22, 2022

Conditions

Infertility, Female

Keywords

in vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • Oocytes (Intention-to-Treat, ITT)

    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.

    From date of randomization up to 18 days

Secondary Outcomes (11)

  • Number of Follicles With Size ≥ 16 mm

    From date of randomization up to 16 days

  • Mature Oocytes

    From date of randomization up to 18 days

  • Fertilised Oocytes

    From date of randomization up to 19 days

  • Percentage of Patients With Embryo Transfer

    From date of randomization up to 25 days

  • Total Dose of Follitropin Alfa

    From date of randomization up to 16 days

  • +6 more secondary outcomes

Study Arms (2)

Primapur (Follitropin alfa)

EXPERIMENTAL
Drug: Follitropin alfa (Primapur)

Gonal-f (Follitropin alfa)

ACTIVE COMPARATOR
Drug: Follitropin alfa (Gonal-f)

Interventions

Follitropin alfa (Gonal-f)DRUG

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

Gonal-f (Follitropin alfa)
Follitropin alfa (Primapur)DRUG

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

Primapur (Follitropin alfa)

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

AltraVita IVF clinic

Moscow, Russia

Location

Perinatal Medical Center

Moscow, Russia

Location

Clinical Hospital Lapino

Moscow Oblast, Russia

Location

Related Publications (4)

  • 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.

    RESULT

  • Barakhoeva Z, Vovk L, Fetisova Y, Marilova N, Ovchinnikova M, Tischenko M, Scherbatyuk Y, Kolotovkina A, Miskun A, Kasyanova G, Teterina T, Zorina I, Belousova N, Morozova E, Yakovenko S, Apryshko V, Sichinava L, Shalinsmall a, Cyrillic R, Polzikov M. A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:6-12. doi: 10.1016/j.ejogrb.2019.07.032. Epub 2019 Jul 26.

    PMID: 31400644RESULT

  • Barakhoeva Z.B., Vovk L.A., Zorina I.V., Belousova N.Y., Teterina T.A., Yakovenko S.A., Apryshko V.P., Fetisova Y.A., Marilova N.A., Morozova E.G., Ovchinnikova M.M., Tishenko M.A., Sherbatyuk Y.V., Kolotovkina A.V., Miskun A.A., Kasyanova G.V., Sichinava L.G., Shalinа R.I., Polzikov M.A. Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®). Akusherstvo, ginekologiya i reprodukciya. 2018;12(3):5-16. (In Russ.) https://doi.org/10.17749/2313-7347.2018.12.3.005-016

    RESULT

  • Polzikov M, Blinov D, Barakhoeva Z, Vovk L, Fetisova Y, Ovchinnikova M, Tischenko M, Zorina I, Yurasov V, Ushakova T, Sergeyev O. Association of the Serum Folate and Total Calcium and Magnesium Levels Before Ovarian Stimulation With Outcomes of Fresh In Vitro Fertilization Cycles in Normogonadotropic Women. Front Endocrinol (Lausanne). 2022 Feb 11;13:732731. doi: 10.3389/fendo.2022.732731. eCollection 2022.

    PMID: 35222266DERIVED

Related Links

MeSH Terms

Conditions

Infertility, Female

Interventions

follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Results Point of Contact

Title
Mikhail Polzikov (PhD)
Organization
IVFarma LLC
mikhail.polzikov@ivfarma.ru
+74996455342

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2017

First Posted

March 23, 2017

Study Start

February 8, 2017

Primary Completion

August 17, 2018

Study Completion

August 17, 2018

Last Updated

April 1, 2022

Results First Posted

June 6, 2019

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(3)