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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01426386
First received: August 30, 2011
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Number of oocytes retrieved [ Time Frame: End of stimulation (10-15 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and size of follicles during stimulations [ Time Frame: Up to 16 days ] [ Designated as safety issue: No ]
  • Endocrine profile measured by circulating levels of hormones [ Time Frame: Up to 16 days ] [ Designated as safety issue: No ]
  • Total IMP (investigational medicinal product) dose administered measured from first until last dose (end of stimulation) [ Time Frame: Up to 16 days ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Successful pregnancy rate [ Time Frame: 5-6 weeks ] [ Designated as safety issue: No ]
  • Frequency and intensity of adverse events [ Time Frame: From signing ICF (informed consent form) until end of trial visit = 8-9 weeks ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01426386     History of Changes
Other Study ID Numbers: 000009, 2011-000633-36
Study First Received: August 30, 2011
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ethics Committee
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee

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

ClinicalTrials.gov processed this record on September 30, 2014