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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 31, 2011
Last Update Posted: June 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ferring Pharmaceuticals
This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.

Condition Intervention Phase
Infertility Drug: FE 999049 Drug: Gonal - F Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Number of oocytes retrieved [ Time Frame: End of stimulation (10-15 days) ]

Secondary Outcome Measures:
  • Number and size of follicles during stimulations [ Time Frame: Up to 16 days ]
  • Endocrine profile measured by circulating levels of hormones [ Time Frame: Up to 16 days ]
  • Total IMP (investigational medicinal product) 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 until embryo transfer) ]
  • Successful pregnancy rate [ Time Frame: 5-6 weeks ]
  • Frequency and intensity of adverse events [ Time Frame: From signing ICF (informed consent form) until end of trial visit = 8-9 weeks ]

Enrollment: 265
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426386

UZ Brussel
Brussels, Belgium
UZ Gent
Gent, Belgium
Czech Republic
Prague, Czech Republic
Copenhagen, Denmark
IU Dexeus
Barcelona, Spain
IVI Madrid
Madrid, Spain
IVI Sevilla
Sevilla, Spain
IVI Valencia
Valencia, Spain
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01426386     History of Changes
Other Study ID Numbers: 000009
2011-000633-36 ( EudraCT Number )
First Submitted: August 30, 2011
First Posted: August 31, 2011
Last Update Posted: June 25, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female