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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02309671

Enrollment

159

Registered

2014-12-05

Start date

2014-12-31

Completion date

2016-09-30

Last updated

2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

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

Interventions

DRUGFE 999049

DRUGfollitropin beta

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 39 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026