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

IVFarma

Status and phase: Completed; Phase 3

Conditions: Infertility, Female

Treatments: Drug: Follitropin alfa (Primapur); Drug: Follitropin alfa (Gonal-f)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03088137

FSG-03-01

Details and patient eligibility

About

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

Enrollment: 118 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

Primapur (Follitropin alfa)

Experimental group

Treatment:

Drug: Follitropin alfa (Primapur)

Gonal-f (Follitropin alfa)

Active Comparator group

Treatment:

Drug: Follitropin alfa (Gonal-f)