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

IVFarma LLC3 sites in 1 country118 target enrollmentFebruary 8, 2017

ConditionsInfertility, Female

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

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

Overview

Phase: Phase 3
Intervention: Follitropin alfa (Primapur)
Conditions: Infertility, Female
Sponsor: IVFarma LLC
Enrollment: 118
Locations: 3
Primary Endpoint: Oocytes (Intention-to-Treat, ITT)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 8, 2017

End Date

August 17, 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

IVFarma LLC

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Primapur (Follitropin alfa)

Intervention: Follitropin alfa (Primapur)

Gonal-f (Follitropin alfa)

Intervention: Follitropin alfa (Gonal-f)

Outcomes

Primary Outcomes

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

Percentage of Patients With the Evidence for Clinical Pregnancy(The 10th week after embryo transfer)
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)
Number of Days of Follitropin Alfa Treatment(From date of randomization up to 16 days)
Number of Patients With Follitropin Alfa Dose Correction(From date of randomization up to 16 days)
Number of Patients With Cycle Cancellation(From date of randomization up to 16 days)
Number of No-responders(From date of randomization up to 8 days)
Percentage of Patients With Serum hCG More Than 25 IU/l(From date of randomization up to 42 days)