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

Phase 2CompletedNCT02309671

Ferring Pharmaceuticals159 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

159

Conditions

Infertility

Interventions

FE 999049DRUG

follitropin betaDRUG

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 39 Years

Medical Language ↔ Plain English

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

Locations (1)

Investigational site (there may be other sites in this country)

Tokyo, Japan

Outcomes

Primary Outcomes

Number of oocytes retrieved

Time frame: End of stimulation (max 16 days after investigational medicinal product (IMP) start)

Secondary Outcomes

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

Data from ClinicalTrials.gov

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