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

March 22, 2022 updated by: IVFarma LLC

Multicentre 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • AltraVita IVF clinic
      • Moscow, Russian Federation
        • Perinatal Medical Center
      • Moscow Oblast, Russian Federation
        • Clinical Hospital Lapino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of randomization up to 18 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization up to 16 days
Mature Oocytes
Time Frame: From date of randomization up to 18 days
The number of mature oocytes (MII stage of development)
From date of randomization up to 18 days
Fertilised Oocytes
Time Frame: From date of randomization up to 19 days
The number of fertilised oocytes with the presence of two pronuclei: 2PN
From date of randomization up to 19 days
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
From date of randomization up to 25 days
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)
From date of randomization up to 16 days
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)
From date of randomization up to 16 days
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)
From date of randomization up to 16 days
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)
From date of randomization up to 16 days
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)
From date of randomization up to 8 days
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)
From date of randomization up to 42 days
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
The 10th week after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVFarma LLC

Collaborators

BridgePharm LLC
GlobalPharma LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2017

Primary Completion (Actual)

August 17, 2018

Study Completion (Actual)

August 17, 2018

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 23, 2017

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSG-03-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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