Title
Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Phase
Phase 3Lead Sponsor
IVFarma LLCStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Infertility, FemaleIntervention/Treatment
follitropin alfa ...Study Participants
118The 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
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
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)
| Event Type | Organ System | Event Term | Primapur (Follitropin Alfa) | Gonal-f (Follitropin Alfa) |
|---|
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.
The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration
The number of mature oocytes (MII stage of development)
The number of fertilised oocytes with the presence of two pronuclei: 2PN
The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up
The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU)
The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation)
The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU)
The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation)
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)
Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer)
Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity
