FOLLITROPIN BETA for Female subfertility | Subfertility requiring ICSI

Inclusion criteria

• {"criterion_text":"- Female age: > 18 to < 40 years\n- No hormonal pre-treatment within the month before the start of the treating cycle\n- Signed informed consent\n- 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 at-tempts)\n- BMI ≤29 Kg /m2\n- Patients of ≤ 36 years old, body weight should be >60kg\n- Patients of >36 years old, body weight should be > 50 kg\n- Regular normo-ovulatory menstrual cycles (26–35 days)\n- 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\n- Normal ultrasound scan (presence of both ovaries without evidence of abnormality within 6 months)\n- AFC >7 and < 20"}

Exclusion criteria

• {"criterion_text":"- Polycystic ovarian syndrome (PCOS) according to the Rotterdam classification(2018)\n- Oocyte donors\n- Poor responder patients (defined by the Bologna criteria (Ferraretti et al., 2011): eligible women had to fulfil at least two of the three following criteria: (i) advanced maternal age (≥40 years) or any other risk factor for poor ovarian response (patients with genetic or ac-quired conditions); (ii) poor ovarian response (≤3 oocytes with a conventional stimulation protocol); (iii) abnormal ovarian reserve test (antral follicle count [AFC] <7 or anti-Müllerian hormone [AMH] <1.1 ng/ml). follow up)\n- Endometriosis ≥ grade 3\n- Contraindications to the use of gonadotropins\n- Abnormal vaginal bleeding of unknown cause\n- 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)\n- A history of recurrent miscarriage (three or more consecutive miscarriages)\n- Surgical obtained sperm (TESE and FNA)"}

Primary endpoints

• {"endpoint_text":"- Mean serum P level on trigger day","definition_or_measurement_approach":"Mean serum progesterone (P) level measured on day of hCG (trigger day), reported in ng/mL. Main objective: Compare the mean serum progesterone level (ng/mL) on day of hCG between the study groups."}

Secondary endpoints

• {"endpoint_text":"- Number of COCs retrieved\n- Number of patients who underwent FA\n- Clinical pregnancy rate\n- Ongoing pregnancy rate\n- Miscarriage rate\n- Live birth rate","definition_or_measurement_approach":"Clinical pregnancy rate: number of viable pregnancies at 6 weeks of gestation per ITT and PP. Ongoing pregnancy rate: number of viable pregnancies at 12 weeks of gestation per ITT and PP. Other endpoints: no further definition/measurement details provided in the record."}

Other endpoints

• {"endpoint_text":"- Number of mature oocytes\n- Number of top quality embryos on Day 3\n- Percentage of patients with a P value above 1.5 ng/mL on the day of hCG","definition_or_measurement_approach":"Number of mature oocytes and number of top quality embryos on Day 3: reported counts as described in secondary objectives. Percentage of patients with a P value above 1.5 ng/mL on day of hCG: proportion of patients with serum progesterone >1.5 ng/mL on trigger day as described in secondary objectives."}

Belgium

Earliest CTIS Part Ii Submission Date

03-10-2024

Latest Decision Or Authorization Date

04-10-2024

Processing Time Days

1

Number Of Sites

3

Number Of Participants

261

Primary sponsor

Full Name

UZ Brussel

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium