A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment

Study Overview
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Brief Summary
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This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.

Official Title
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A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme

Conditions
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Infertility

Intervention / Treatment
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* Drug: FE 999049
* Drug: follitropin beta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility Women eligible for IVF and/or ICSI treatment Women aged 20-39 years Women with body mass index (BMI) of 17.5-32.0 kg/m2 Exclusion Criteria: Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV Women with history of recurrent miscarriage Women with contraindications to controlled ovarian stimulation with gonadotropins Women with three or more controlled ovarian stimulation cycles

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FE 999049 6 µg<br> | Drug: FE 999049<br> <br> |
| Experimental: FE 999049 9 µg<br> | Drug: FE 999049<br> <br> |
| Experimental: FE 999049 12 µg<br> | Drug: FE 999049<br> <br> |
| Active Comparator: FOLLISTIM 150 IU<br>follitropin beta | Drug: follitropin beta<br> <br> * Other names: FOLLISTIM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | End of stimulation (max 16 days after investigational medicinal product (IMP) start) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of follicles during stimulation |  | Up to 16 days | 
| Size of follicles during stimulation |  | Up to 16 days | 
| Endocrine profile measured by circulating levels of hormones |  | Up to 16 days | 
| Total IMP dose administered measured from first until last dose (end of stimulation) |  | Up to 16 days | 
| Embryo quality measured by fertilised oocytes and number and quality of embryos and blastocysts during culturing |  | 5 days (from oocyte retrieval to embryo transfer) | 
| Successful pregnancy rate |  | 5-6 weeks after transfer | 
| Frequency of adverse events |  | From signing informed consent form until end of trial visit = 8-9 weeks | 
| Intensity of adverse events |  | From signing informed consent form until end of trial visit = 8-9 weeks |