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

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ClinicalTrials.gov Identifier: NCT01426386
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : June 25, 2013
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Infertility Drug: FE 999049 Drug: Gonal - F Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
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
Study Start Date : September 2011
Primary Completion Date : April 2012
Study Completion Date : March 2013

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



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

Secondary Outcome Measures :
  1. Number and size of follicles during stimulations [ Time Frame: Up to 16 days ]
  2. Endocrine profile measured by circulating levels of hormones [ Time Frame: Up to 16 days ]
  3. Total IMP (investigational medicinal product) dose administered measured from first until last dose (end of stimulation) [ Time Frame: Up to 16 days ]
  4. 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) ]
  5. Successful pregnancy rate [ Time Frame: 5-6 weeks ]
  6. Frequency and intensity of adverse events [ Time Frame: From signing ICF (informed consent form) until end of trial visit = 8-9 weeks ]


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

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


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

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 Posted: August 31, 2011    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

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