Infertility Clinical Trial
Official title:
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
NCT number | NCT02309671 |
Other study ID # | 000124 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | December 2014 |
Est. completion date | September 2016 |
Verified date | November 2016 |
Source | Ferring Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.
Status | Completed |
Enrollment | 159 |
Est. completion date | September 2016 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 39 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Japan | Investigational site (there may be other sites in this country) | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Ferring Pharmaceuticals |
Japan,
Ishihara O, Klein BM, Arce JC; Japanese Follitropin Delta Phase 2 Trial Group. Randomized, assessor-blind, antimüllerian hormone-strati?ed, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing control — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of oocytes retrieved | End of stimulation (max 16 days after investigational medicinal product (IMP) start) | ||
Secondary | Number of follicles during stimulation | Up to 16 days | ||
Secondary | Size of follicles during stimulation | Up to 16 days | ||
Secondary | Endocrine profile measured by circulating levels of hormones | Up to 16 days | ||
Secondary | Total IMP dose administered measured from first until last dose (end of stimulation) | Up to 16 days | ||
Secondary | Embryo quality measured by fertilised oocytes and number and quality of embryos and blastocysts during culturing | 5 days (from oocyte retrieval to embryo transfer) | ||
Secondary | Successful pregnancy rate | 5-6 weeks after transfer | ||
Secondary | Frequency of adverse events | From signing informed consent form until end of trial visit = 8-9 weeks | ||
Secondary | Intensity of adverse events | From signing informed consent form until end of trial visit = 8-9 weeks |
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