Effect of Recombinant Follicular Stimulating Hormone (FSH) Dosing Following Cori-follitropin Alfa (TBC)
Infertility
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria
- Female age: > 18 to < 38 years
- The patient must have undergone not more than three consecutive unsuccessful IVF/ICSI cycles since the last ongoing pregnancy (whether fresh and/or several frozen ET resulted from these attempts)
- BMI ≤29 Kg /m2
- Patients of ≤ 35 years old, body weight should be ≥ 60kg
- Patients of >35 years old, body weight should be > 50 kg
- Regular normo-ovulatory menstrual cycles (26-35 days)
- Basal FSH <10 IU/l, basal E2 <60 pg/ml and basal Progesteone (< 1.5 ng/mL) (normal cycle day-3 basal serum hormone levels), to be measured on cycle day 2 or 3 of the treatment cycle
- Normal ultrasound scan (presence of both ovaries without evidence of abnormality within 6 months)
- AFC >7 and < 20
- No pill within the 3 months before treatment
- Signed informed consent
Exclusion Criteria
- Polycystic ovarian syndrome (PCOS) according to the Rotterdam classification (2004)
- Oocyte donors
- Poor responder patients (development of <4 follicles in previous IVF/ICSI or cancelled cycles)
- Endometriosis ≥ grade 3
- Contraindications to the use of gonadotropins
- Abnormal vaginal bleeding of unknown cause
- History of ovarian hyperstimulation syndrome (OHSS) or a previous ovarian stimulation cycle with more than 30 follicles of 11 mm or higher (as recommended by the Elonva® Summary of Product Characteristics)
- A history of recurrent miscarriage (three or more consecutive miscarriages)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
group A
groppo B
Group C
The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A).
The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 150IU (Group B)
The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 250IU (Group C) of recFSH (Puregon®, MSD).