A randomised, controlled, assessor-blind, parallel groups, multinational,multicentre trial assessing the dose-response relationship of FE 999049in controlled ovarian stimulation in women undergoing an assistedreproductive technology programme
- Conditions
- InfertilityMedDRA version: 14.0Level: PTClassification code 10021926Term: InfertilitySystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2011-000633-36-DK
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 330
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>To evaluate the efficacy of FE 999049 with respect to achieving pregnancy<br>To assess the population pharmacokinetics of FE 999049 <br>To evaluate the safety profile of FE 999049<br>To evaluate the local tolerability of FE 999049 following subcutaneous administration<br>To evaluate the immunogenicity of FE 999049<br>;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:<br><br>•=3 follicles with a diameter =17 mm <br><br>
- Secondary Outcome Measures
Name Time Method