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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309671
• Other study ID #: 000124
• Status: Completed
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• FE 999049

• follitropin beta

Locations

Country	Name	City	State
Japan	Investigational site (there may be other sites in this country)	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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

Outcome

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