A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/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 women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.

Official Title
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A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme

Conditions
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Infertility

Intervention / Treatment
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* Drug: FE 999049
* Drug: Gonal - F


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 (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment Women aged 18-37 years Women with body mass index (BMI) of 18.5-32.0 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: 18 Years
Maximum Age: 37 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: 5.2 µg<br> | Drug: FE 999049<br> <br> |
| Experimental: 6.9 µg<br> | Drug: FE 999049<br> <br> |
| Experimental: 8.6 µg<br> | Drug: FE 999049<br> <br> |
| Experimental: 10.3 µg<br> | Drug: FE 999049<br> <br> |
| Experimental: 12.1 µg<br> | Drug: FE 999049<br> <br> |
| Active Comparator: 11 µg FbM (150 IU)<br> | Drug: Gonal - F<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Oocytes Retrieved |  | Day of oocyte retrieval (up to Day 18 after start of stimulation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Size of Follicles During Stimulation | Follicular volume at end of stimulation | End of stimulation (up to 16 stimulation days) | 
| Endocrine Profile | Estradiol at end of stimulation | End of stimulation (up to 16 stimulation days) | 
| Total IMP Dose |  | End of stimulation (up to 16 stimulation days) | 
| Number of Fertilised Oocytes | An oocyte with 2 pronuclei was regarded as correctly fertilised | Day 1 after insemination | 
| Number and Quality of Blastocysts on Day 5 | Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher | Day 5 after oocyte retrieval | 
| Clinical Pregnancy With Fetal Heart Beat Rate | Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat | 5-6 weeks after transfer | 
| Frequency and Intensity of Adverse Events |  | From signing informed consent form until end of trial visit (up to 5 months) |