NCT03088137CompletedPhase 3
Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- IVFarma LLC
- Enrollment
- 118
- Locations
- 3
- Primary Endpoint
- Oocytes (Intention-to-Treat, ITT)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Primapur (Follitropin alfa)
Experimental
Intervention: Follitropin alfa (Primapur) (Drug)
Gonal-f (Follitropin alfa)
Active Comparator
Intervention: Follitropin alfa (Gonal-f) (Drug)
Outcomes
Primary Outcomes
Oocytes (Intention-to-Treat, ITT)
Time Frame: 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 Outcomes
- Percentage of Patients With the Evidence for Clinical Pregnancy(The 10th week after embryo transfer)
- Number of Follicles With Size ≥ 16 mm(From date of randomization up to 16 days)
- Mature Oocytes(From date of randomization up to 18 days)
- Fertilised Oocytes(From date of randomization up to 19 days)
- Percentage of Patients With Embryo Transfer(From date of randomization up to 25 days)
- Total Dose of Follitropin Alfa(From date of randomization up to 16 days)
- Number of Days of Follitropin Alfa Treatment(From date of randomization up to 16 days)
- Number of Patients With Follitropin Alfa Dose Correction(From date of randomization up to 16 days)
- Number of Patients With Cycle Cancellation(From date of randomization up to 16 days)
- Number of No-responders(From date of randomization up to 8 days)
- Percentage of Patients With Serum hCG More Than 25 IU/l(From date of randomization up to 42 days)
Investigators
Study Sites (3)
Loading locations...
Similar Trials
Completed
Not Applicable
A multi centre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss.Hair lossNL-OMON26657eids Universitair Medisch Centrum in Leiden260
Terminated
Phase 4
Intravenous (IV) Solutions for Dehydration in Children With GastroenteritisDehydrationGastroenteritisNCT01234883Baxter Healthcare Corporation100
Completed
Phase 3
Study to Assess the Efficacy and Safety of Dysport® in Cervical DystoniaCervical DystoniaNCT00447772Ipsen516
Active, not recruiting
Phase 1
A multicentre study to assess the safety and efficacy of sodium hyaluronate (Hyalgan-F) produced by fermentation in knee psteoarthritis.Knee oasteoarthritisEUCTR2005-002735-27-LVFidia Farmaceutici SpA120
Completed
Not Applicable
A clinical multicenter study on efficacy and safety of C1-inhibitor concentrate for clinical amniotic fluid embolismJPRN-UMIN000015686Obstetrics and Gynecology, Hamamatsu University School of Medicine.30