A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment

October 26, 2020 updated by: Ferring Pharmaceuticals

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme

This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

265

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

  • Belgium
      • Brussels, Belgium
        • UZ Brussel
      • Gent, Belgium
        • UZ Gent
  • Czechia
      • Prague, Czechia
        • ICF CUBE
  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet
  • Spain
      • Barcelona, Spain
        • IU Dexeus
      • Madrid, Spain
        • IVI Madrid
      • Sevilla, Spain
        • IVI Sevilla
      • Valencia, Spain
        • IVI Valencia

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

18 years to 37 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 (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment
  • Women aged 18-37 years
  • Women with body mass index (BMI) of 18.5-32.0 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: 5.2 µg
Drug: FE 999049
Experimental: 6.9 µg
Drug: FE 999049
Experimental: 8.6 µg
Drug: FE 999049
Experimental: 10.3 µg
Drug: FE 999049
Experimental: 12.1 µg
Drug: FE 999049
Active Comparator: 11 µg FbM (150 IU)
Drug: Gonal - F

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Oocytes Retrieved
Time Frame: Day of oocyte retrieval (up to Day 18 after start of stimulation)
Day of oocyte retrieval (up to Day 18 after start of stimulation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Size of Follicles During Stimulation
Time Frame: End of stimulation (up to 16 stimulation days)
Follicular volume at end of stimulation
End of stimulation (up to 16 stimulation days)
Endocrine Profile
Time Frame: End of stimulation (up to 16 stimulation days)
Estradiol at end of stimulation
End of stimulation (up to 16 stimulation days)
Total IMP Dose
Time Frame: End of stimulation (up to 16 stimulation days)
End of stimulation (up to 16 stimulation days)
Number of Fertilised Oocytes
Time Frame: Day 1 after insemination
An oocyte with 2 pronuclei was regarded as correctly fertilised
Day 1 after insemination
Number and Quality of Blastocysts on Day 5
Time Frame: Day 5 after oocyte retrieval
Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher
Day 5 after oocyte retrieval
Clinical Pregnancy With Fetal Heart Beat Rate
Time Frame: 5-6 weeks after transfer
Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat
5-6 weeks after transfer
Frequency and Intensity of Adverse Events
Time Frame: From signing informed consent form until end of trial visit (up to 5 months)
From signing informed consent form until end of trial visit (up to 5 months)

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

September 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

August 31, 2011

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000009
  • 2011-000633-36 (EudraCT Number)

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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