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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00829244 |
The overall objective of this trial is to compare the ovarian response in ART subjects administered GONAL f® according to the CONSORT calculator versus given a standard GONAL f® dose of 150 IU per day.
Condition | Intervention | Phase |
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Infertility |
Drug: GONAL f® prefilled pen |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase IV Prospective, Multicentre, Randomized, Open-Label Trial to Assess the Efficacy and Safety of GONAL f® at a Dose Based on Subject Baseline Characteristics Determined According to the CONSORT Calculator Compared With a Standard Dose of GONAL f® 150 IU Per Day for Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology (ART) |
Estimated Enrollment: | 200 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: GONAL f® prefilled pen
GONAL f® doses starting at minimum of 112.5 IU per day and a maximum of 450 IU per day for one cycle only
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2: Active Comparator |
Drug: GONAL f® prefilled pen
GONAL f® standard treatment arm (150 IU of GONAL f® per day) up to day 5 of stimulation after which the dose can be adjusted based upon the subject's ovarian response and according to the centre's standard practice.
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Ages Eligible for Study: | 18 Years to 34 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |
Research Site | Recruiting |
Geneva, Switzerland | |
Contact: Local Medical Information +41-41-747-0812 |
Study Director: | Mark O'Brien, MD | Merck Serono S.A. - Geneva |
Responsible Party: | Merck Serono S.A. - Geneva, an Affiliate of Merck KGaA Darmstadt, Germany ( Shelly Bustion ) |
Study ID Numbers: | 28613 |
Study First Received: | January 22, 2009 |
Last Updated: | March 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00829244 History of Changes |
Health Authority: | Australia: Human Research Ethics Committee; Chile: Comisión Nacional de Investigación Científica y Tecnológica; Chile: Instituto de Salud Publica de Chile; Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: The Regional Committee on Biomedical Research Ethics; France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; France: National Consultative Ethics Committee for Health and Life Sciences; Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ethics Committee; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Spain: Comité Ético de Investigación Clínica; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board; Switzerland: Ethikkommission; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee |
Infertility Assisted reproductive technology |
Genital Diseases, Female Infertility Genital Diseases, Male |
Genital Diseases, Female Infertility Genital Diseases, Male |