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

Phase 3

Completed

• Conditions: Infertility, Female
• Interventions: Drug: Follitropin alfa (Gonal-f); Drug: Follitropin alfa (Primapur)

• Registration Number: NCT03088137
• Lead Sponsor: IVFarma LLC

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-08
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-23
• Primary Completion: 2018-08-17
• Study Completion: 2018-08-17
• Results First Submitted: 2018-10-13
• Results First Submitted QC: 2019-06-05
• Results First Posted: 2019-06-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gonal-f (Follitropin alfa)	Follitropin alfa (Gonal-f)	-
Primapur (Follitropin alfa)	Follitropin alfa (Primapur)	-

Primary Outcome Measures

Name	Time	Method
Oocytes (Intention-to-Treat, ITT)	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 Outcome Measures

Name	Time	Method
Percentage of Patients With the Evidence for Clinical Pregnancy	The 10th week after embryo transfer	Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity
Number of Follicles With Size ≥ 16 mm	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
Mature Oocytes	From date of randomization up to 18 days	The number of mature oocytes (MII stage of development)
Fertilised Oocytes	From date of randomization up to 19 days	The number of fertilised oocytes with the presence of two pronuclei: 2PN
Percentage of Patients With Embryo Transfer	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
Total Dose of Follitropin Alfa	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)
Number of Days of Follitropin Alfa Treatment	From date of randomization up to 16 days	The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation)
Number of Patients With Follitropin Alfa Dose Correction	From date of randomization up to 16 days	The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU)
Number of Patients With Cycle Cancellation	From date of randomization up to 16 days	The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation)
Number of No-responders	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)
Percentage of Patients With Serum hCG More Than 25 IU/l	From date of randomization up to 42 days	Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer)

Trial Locations

Locations (3)

AltraVita IVF clinic; 🇷🇺 Moscow, Russian Federation

Clinical Hospital Lapino; 🇷🇺 Moscow Oblast, Russian Federation

Perinatal Medical Center; 🇷🇺 Moscow, Russian Federation