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Sponsored by: |
EMD Serono |
Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00249834 |
CONSORT = Clinical validation of the ART treatment guidelines, which determine the optimal dose of r hFSH based on subject baseline characteristics/predictors of ovarian response.
Phase IIIb/IV, open-label, multi-centre, multi-regional study. Subject will first be treated with a GnRH agonist according to centre's standard practice (no depot formulation will be allowed). Down-regulation is to be confirmed by E2 levels and/or US scan depending on centre's standard practice. Subject will then start r-hFSH treatment (Gonal-f® Prefilled Pen) at a pre-defined, fixed dose according to the provided ART treatment guidelines. Dose adjustment will be allowed strictly in case of risk of OHSS. Once follicular development is adequate (ie. at least 1 follicle ≥ 18mm and 2 follicles ≥ 16mm), a single injection of 250 mcg of r-hCG (Ovid[t]rel [le]®) will be administered.
Ovum Pick Up (OPU), in vitro fertilisation (IVF) and embryo transfer (ET) will be performed as per centre's standard practice.
A post-treatment safety visit will be performed for all subjects on days 15-20 post-hCG.
Condition | Intervention | Phase |
Infertility |
Other: CONSORT calculator |
Phase IV |
MedlinePlus related topics: | Infertility |
ChemIDplus related topics: | Follitropin beta Urofollitropin BaseLine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Enrollment: | 166 |
Study Start Date: | September 2004 |
Study Completion Date: | May 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Other: CONSORT calculator
The subject's Age, Body Mass Index (kg/m2), Number of follicles < 11 mm on a baseline ultrasound scan, Serum FSH level in the early follicular phase of a menstrual cycle were entered in an algorithm (CONSORT calculator), which then calculated the optimal fixed starting dose of r-hFSH for each subject according to her individual characteristics.
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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:
Full FDA approved prescribing information can be found here 
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Responsible Party: | Merck Serono International S.A., Geneva, Switzerland ( Shelly Bustion ) |
Study ID Numbers: | 25198 |
First Received: | November 4, 2005 |
Last Updated: | January 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00249834 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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