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

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: FE 999049; Drug: follitropin beta

• Registration Number: NCT02309671
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-28
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-05
• Primary Completion: 2015-11
• Study Completion: 2016-09
• Status Verified: 2016-11
• Disposition First Submitted: 2016-11-04
• Disposition First Submitted QC: 2016-11-04
• Disposition First Posted: 2016-11-06
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FE 999049 9 µg	FE 999049	-
FE 999049 12 µg	FE 999049	-
FE 999049 6 µg	FE 999049	-
FOLLISTIM 150 IU	follitropin beta	follitropin beta

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Investigational site (there may be other sites in this country); 🇯🇵 Tokyo, Japan