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

December 11, 2020 updated by: Ferring Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Investigational site (there may be other sites in this country)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FE 999049 6 µg
Drug: FE 999049
Experimental: FE 999049 9 µg
Drug: FE 999049
Experimental: FE 999049 12 µg
Drug: FE 999049
Active Comparator: FOLLISTIM 150 IU
follitropin beta
Drug: follitropin beta
Other Names:
  • FOLLISTIM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of follicles during stimulation
Time Frame: Up to 16 days
Up to 16 days
Size of follicles during stimulation
Time Frame: Up to 16 days
Up to 16 days
Endocrine profile measured by circulating levels of hormones
Time Frame: Up to 16 days
Up to 16 days
Total IMP dose administered measured from first until last dose (end of stimulation)
Time Frame: Up to 16 days
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)
5 days (from oocyte retrieval to embryo transfer)
Successful pregnancy rate
Time Frame: 5-6 weeks after transfer
5-6 weeks after transfer
Frequency of adverse events
Time Frame: From signing informed consent form until end of trial visit = 8-9 weeks
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
From signing informed consent form until end of trial visit = 8-9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000124

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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