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).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility|
- The proportion of patients who reach the criteria for hCG-administration within 14 days of FSH stimulation. [ Time Frame: 14 days of FSH stimulation ] [ Designated as safety issue: Yes ]
The HCG-criteria is defined as:
- One follicle with a diameter of >17 mm or two or three follicles > 15 mm (verified by transvaginal ultrasound).
- HCG should not be given if there is no response after 35 days or > 4 follicles > 15 mm (unless converted to IVF/ICSI).
- If a patient is seen with one to three follicles of 15 - 16 mms HCG can be administered on the same or on the next day due to a presumed growth of follicles of + 2 mm/day.
- Endocrinological characteristics and follicular dynamics of anovulatory infertility WHO Group II [ Time Frame: 35 days ] [ Designated as safety issue: No ]Prediction of FSH response in anovulatory infertility WHO Group II based on endocrinology, sonography, FSH-receptor status and demography
|Study Start Date:||December 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Experimental: Ovulation induction||
The medication used in this study is the follicle-stimulating hormone "highly purified human menopausal gonadotrophin" (HP-HMG), Menopur, (Ferring a/s).
Stimulation with HP-hMG (Menopur) is started on day 2-5 of menstrual bleeding.The HP-hMG starting dose is calculated based on the nomogram predicting the threshold dose. The dose-range is from 75 IU/day to 187.5 IU/day.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01250821
|The Fertility Clinic, Section 4071, Rigshospitalet|
|Copenhagen, Denmark, DK-2100|
|Principal Investigator:||Mette P Lauritsen, MD||Rigshospitalet, Denmark|
|Study Chair:||Anders N Andersen, Prof. MD||Rigshospitalet, Denmark|