Overview

This trial has been completed.

Condition infertility
Treatments fe 999049, follitropin beta
Phase phase 2
Sponsor Ferring Pharmaceuticals
Start date December 2014
End date November 2015
Trial size 159 participants
Trial identifier NCT02309671, 000124

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
fe 999049
(Experimental)
fe 999049
(Experimental)
fe 999049
(Active Comparator)
follitropin beta
follitropin beta FOLLISTIM

Primary Outcomes

Measure
Number of oocytes retrieved
time frame: End of stimulation (max 16 days after investigational medicinal product (IMP) start)

Secondary Outcomes

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

Eligibility Criteria

Female participants from 20 years up to 39 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Ferring Pharmaceuticals.