Infertility Clinical Trial
Official title:
Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility
Ovulation disorders are a common cause of infertility in women. Most of these women can be
classified as World Health Organization (WHO) Group II anovulatory patients as they have
irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation
hormone (FSH) and estradiol.
The purpose of this study is to optimize the low-dose-step-up protocol traditionally used
for ovulation induction with follicle-stimulating hormone (FSH) in women with anovulatory
infertility WHO Group II.
Previous studies have established that menstrual cycle history, mean ovarian volume and BMI
are significant predictors of FSH threshold dose in women with anovulatory infertility WHO
Group II undergoing ovulation induction (Nyboe Andersen et al., 2008). A FSH dosage nomogram
has been constructed based on these variables.
The aim of this study is to evaluate the clinical use of the nomogram in order to test the
use of the variables to determine whether an individualized starting dose of FSH can be used
for ovulation induction in anovulatory patients.
It is the hypothesis that an individualized starting dose of gonadotrophin will minimize the
disadvantages of the treatment and that the stimulation period of the individualized
nomogram-based treatment will be 25% shorter than observed in the standard protocol.
The primary endpoint is the proportion of patients who reach the criteria for
hCG-administration within 14 days of Menopur stimulation. The results of the study will be
compared with the data obtained in the Menopur Ovulation Induction Trial (Platteau et al.,
2006).
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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