Infertility MedDRA version: 14.0 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: FE 999049
Product Code: FE 999049
Pharmaceutical Form: Solution for injection
Current Sponsor code: FE 999049
Other descriptive name: human recombinant follicle-stimulating hormone
Conce
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for IVF and/or ICSI treatment will be included in this trial. Subjects will be 18-37 years of age, with a body mass index (BMI) of 18.5-32.0 kg/m2 and have serum AMH levels within 5.0-44.9 pmol/L at the screening visit based on the central laboratory analysis. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 330 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV, history of recurrent miscarriage or with contraindications to controlled ovarian stimulation with gonadotropins will be excluded from participation in this trial. Women with three or more controlled ovarian stimulation cycles will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the dose-response relationship of FE 999049 with respect to ovarian response in patients undergoing controlled ovarian stimulation;Secondary Objective: To evaluate the dose-response relationship of FE 999049 with respect to endocrine profile, oocyte fertilisation, number and quality of embryos and treatment efficiency To evaluate the efficacy of FE 999049 with respect to achieving pregnancy To assess the population pharmacokinetics of FE 999049 To evaluate the safety profile of FE 999049 To evaluate the local tolerability of FE 999049 following subcutaneous administration To evaluate the immunogenicity of FE 999049;Primary end point(s): Number of oocytes retrieved;Timepoint(s) of evaluation of this end point: Oocyte retrieval is performed when the following criteria is met: ? ?3 follicles with a diameter ?17 mm | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number and size of follicles during stimulation 2. Circulating levels of FSH during stimulation and FSH population pharmacokinetic parameters 3. Circulating levels of LH, inhibin A, inhibin B, estradiol, progesterone, total testosterone and sex hormone binding globulin (SHBG) (free androgen index (FAI) to be calculated) during stimulation 4. Total FE 999049 or GONAL-F dose administered and number of stimulation days 5. Number of fertilised oocytes and fertilisation rate as well as number and quality of embryos on day 3 and blastocysts on day 5 6. Positive ?hCG rate (positive serum ?hCG test 13-15 days after embryo transfer) 7. Clinical pregnancy (with fetal heart beat) rate (transvaginal ultrasound showing at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after embryo transfer) 8. Frequency and intensity of adverse events 9. Changes in circulating levels of clinical chemistry and haematology parameters and proportion of subjects with markedly abnormal changes 10. Frequency and intensity of injection site reactions (redness, pain, itching, swelling and bruising) assessed by the subject three times daily during the stimulation period 11. Proportion of subjects with treatment-induced anti-FSH antibodies 12. Proportion of subjects with treatment-induced anti-FSH antibodies with neutralising capacity;Timepoint(s) of evaluation of this end point: 1. Evaluated at each visit during stimulation 2. Day 4, day 6 and each subsequent stimulation visits 3. Day 4, day 6 and each subsequent stimulation visits 4. End of stimulation day 5. Day 0 to day 5 after oocyte retrieval 6. ?hCG test 13-15 days after embryo transfer 7. 5-6 weeks after embryo transfer 8. From signing informed consent until end of trial visit 9. End of stimulation and End of trial 10. Evaluated 3 times daily during the stimulation period 11. 8-10 days after last IMP dose and 21-28 days after last IMP dose 12. Evaluation performed after last sample, first sampl | — |
Countries
Belgium, Czech Republic, Denmark, Spain
Contacts
Public ContactClinical Development Support
Ferring Pharmaceuticals A/S
Outcome results
None listed