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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
118
Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
AltraVita IVF clinic
Moscow, Russia
Perinatal Medical Center
Moscow, Russia
Clinical Hospital Lapino
Moscow Oblast, Russia
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.
Time frame: From date of randomization up to 18 days
Number of Follicles With Size ≥ 16 mm
The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration
Time frame: From date of randomization up to 16 days
Mature Oocytes
The number of mature oocytes (MII stage of development)
Time frame: From date of randomization up to 18 days
Fertilised Oocytes
The number of fertilised oocytes with the presence of two pronuclei: 2PN
Time frame: From date of randomization up to 19 days
Percentage of Patients With Embryo Transfer
The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up
Time frame: From date of randomization up to 25 days
Total Dose of Follitropin Alfa
The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU)
Time frame: From date of randomization up to 16 days
Number of Days of Follitropin Alfa Treatment
The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From date of randomization up to 16 days
Number of Patients With Follitropin Alfa Dose Correction
The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU)
Time frame: From date of randomization up to 16 days
Number of Patients With Cycle Cancellation
The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation)
Time frame: From date of randomization up to 16 days
Number of No-responders
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)
Time frame: From date of randomization up to 8 days
Percentage of Patients With Serum hCG More Than 25 IU/l
Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer)
Time frame: From date of randomization up to 42 days
Percentage of Patients With the Evidence for Clinical Pregnancy
Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity
Time frame: The 10th week after embryo transfer