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

Primary Purpose

Infertility

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

FE 999049

follitropin beta

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

FE 999049 6 µg

FE 999049 9 µg

FE 999049 12 µg

FOLLISTIM 150 IU

Arm Description

follitropin beta

Outcomes

Primary Outcome Measures

Number of oocytes retrieved

Secondary Outcome Measures

Number of follicles during stimulation

Size of follicles during stimulation

Endocrine profile measured by circulating levels of hormones

Total IMP dose administered measured from first until last dose (end of stimulation)

Embryo quality measured by fertilised oocytes and number and quality of embryos and blastocysts during culturing

Successful pregnancy rate

Frequency of adverse events

Intensity of adverse events

Full Information

NCT ID

NCT02309671

First Posted

November 28, 2014

Last Updated

December 11, 2020

Sponsor

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02309671

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FE 999049 6 µg

Arm Type

Experimental

Arm Title

FE 999049 9 µg

Arm Type

Experimental

Arm Title

FE 999049 12 µg

Arm Type

Experimental

Arm Title

FOLLISTIM 150 IU

Arm Type

Active Comparator

Arm Description

follitropin beta

Intervention Type

Drug

Intervention Name(s)

FE 999049

Intervention Type

Drug

Intervention Name(s)

follitropin beta

Other Intervention Name(s)

FOLLISTIM

Primary Outcome Measure Information:

Title

Number of oocytes retrieved

Time Frame

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

Secondary Outcome Measure Information:

Title

Number of follicles during stimulation

Time Frame

Up to 16 days

Title

Size of follicles during stimulation

Time Frame

Up to 16 days

Title

Endocrine profile measured by circulating levels of hormones

Time Frame

Up to 16 days

Title

Total IMP dose administered measured from first until last dose (end of stimulation)

Time Frame

Up to 16 days

Title

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)

Title

Successful pregnancy rate

Time Frame

5-6 weeks after transfer

Title

Frequency of adverse events

Time Frame

From signing informed consent form until end of trial visit = 8-9 weeks

Title

Intensity of adverse events

Time Frame

From signing informed consent form until end of trial visit = 8-9 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Development Support

Organizational Affiliation

Ferring Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

33272623

Citation

Ishihara O, Klein BM, Arce JC; Japanese Follitropin Delta Phase 2 Trial Group. Randomized, assessor-blind, antimullerian hormone-stratified, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta. Fertil Steril. 2021 Jun;115(6):1478-1486. doi: 10.1016/j.fertnstert.2020.10.059. Epub 2020 Dec 4.

Results Reference

result

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

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