Infertility MedDRA version: 16.0 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This trial will include women undergoing their first IVF/ICSI cycle and aged 18-40 years. They have been diagnosed with tubal infertility, endometriosis stage I/II or have partners diagnosed with male factor infertility, and are considered eligible for IVF or ICSI. The allowed body mass index (BMI) is 17.5 – 32.0 kg/m2, thus including underweight, normal weight, overweight and obese patients. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1350 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects with endometriosis stage III/IV, known history of recurrent miscarriage or with contraindications to controlled ovarian stimulation with gonadotropins will be excluded from participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate and ongoing implantation rate in the fresh cycle in women undergoing controlled ovarian stimulation;Secondary Objective: To compare the clinical benefits of FE 999049 in its dosing regimen to those of GONAL-F with respect to efficacy and safety To compare FE 999049 with GONAL-F with respect to ovarian response including follicular development and endocrine profile, as well as with respect to embryo development To compare FE 999049 with GONAL-F with respect to treatment efficiency To compare FE 999049 with GONAL-F with respect to safety profile, including adverse events, routine safety laboratory parameters and local tolerability To evaluate the immunogenicity of FE 999049 after one treatment cycle To compare FE 999049 with GONAL-F with respect to cost-effectiveness;Primary end point(s): 1. Ongoing pregnancy rate (at least one intrauterine viable fetus 10-11 weeks after transfer) 2. Ongoing implantation rate (number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocytes transferred) ;Timepoint(s) of evaluation of this end point: 1. 10-11 weeks after transfer 2. 10-11 weeks after transfer | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Positive ßhCG (positive serum ßhCG test 13-15 days after transfer) 2. Clinical pregnancy rate (at least one gestational sac 5-6 weeks after transfer) 3. Vital pregnancy rate (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer) 4. Implantation rate (number of gestational sacs 5-6 weeks after transfer divided by number of blastocytes transferred) 5. Proportion of subjects with extreme ovarian responses, defined as < 4, = 15 or = 20 oocytes retrieved 6. Proportion of subjects with early OHSS (including OHSS of moderate/severe grade) and/or preventive interventions for early OHSS 7. Proportion of subjects with cycle cancellation due to poor ovarian response or excessive ovarian response 8. Number and size of follicles on stimulation day 6 and end-of-stimulation 9. Percentage of metaphase II oocytes (only applicable for those inseminated using ICSI), fertilization rate as well as number and quality of embryos on day 3 and blastocytes on day 5 after oocyte retrieval 10. Circulating concentrations of FSH, LH, estradiol, progesterone, inhibin A and inhibin B on stimulation day 6 and end-of-stimulation 11. Total gonadotropin dose and number of stimulation days 12. Frequency and intensity of adverse events 13. Changes in circulating levels of clinical chemistry and haematology parameters and proportion of subjects with markedly abnormal changes 14. Frequency and intensity of injection site reactions (redness, pain, itching, swelling and bruising) assessed by subject during the stimulation period;Timepoint(s) of evaluation of this end point: 1. 13-15 days after transfer 2. 5-6 weeks after transfer 3. 5-6 weeks after transfer 4. 5-6 weeks after transfer 5. Oocyte retrieval visit 6. 9 days after triggering 7. End-of-stimulation 8. Stimulation day 6 and end-of-stimimulation 9. Prior to insemination, culture day 1, culture day 3 and culture day 5 10. Stimulation day 6 and end-of-stimulation 11. | — |
Countries
Belgium, Brazil, Canada, Czech Republic, Denmark, European Union, Italy, Mexico, Poland, Russian Federation, Spain, United Kingdom
Contacts
Public ContactClinical Development Support
Ferring Pharmaceuticals A/S
Outcome results
None listed