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

• Status: Completed
• Trial end date: 2018-08-17
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IVFarma LLC
• Collaborators: BridgePharm LLC; GlobalPharma LLC
• Treatments: Follicle Stimulating Hormone

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

• 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)