Clinical trial NCT02309671: A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 159
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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
* 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

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: End of stimulation (max 16 days after investigational medicinal product (IMP) start)
Secondary outcomes:
measure: Number of follicles during stimulation
timeFrame: Up to 16 days
measure: Size of follicles during stimulation
timeFrame: Up to 16 days
measure: Endocrine profile measured by circulating levels of hormones
timeFrame: Up to 16 days
measure: Total IMP dose administered measured from first until last dose (end of stimulation)
timeFrame: Up to 16 days
measure: Embryo quality measured by fertilised oocytes and number and quality of embryos and blastocysts during culturing
timeFrame: 5 days (from oocyte retrieval to embryo transfer)
measure: Successful pregnancy rate
timeFrame: 5-6 weeks after transfer
measure: Frequency of adverse events
timeFrame: From signing informed consent form until end of trial visit = 8-9 weeks
measure: Intensity of adverse events
timeFrame: From signing informed consent form until end of trial visit = 8-9 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Investigational site (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Ishihara O, Klein BM, Arce JC; Japanese Follitropin Delta Phase 2 Trial Group. Randomized, assessor-blind, antimullerian hormone-stratified, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta. Fertil Steril. 2021 Jun;115(6):1478-1486. doi: 10.1016/j.fertnstert.2020.10.059. Epub 2020 Dec 4.