This study aims to record Efficacy, Safety and tolerability of Gonapure® prescribed for female subjects with infertility Undergoing IVF/ICSI
Gonapure® is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin and contains no luteinizing hormone (LH) activity. FSH stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Gonapure® is the primary hormone responsible for follicular recruitment and development. In order to affect final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following the administration of FSH, when monitoring of the patient indicates that sufficient follicular development has occurred. There is inter-patient variability in response to FSH administration. The dosage and schedule of treatment for female infertility must be determined according to the needs of each patient; it is usual to monitor response by studying the patient's serum oestrogen level and/or by ultrasonic visualization of follicles. Treatment should be started within the first 7 days of the menstrual cycle. Treatment is usually begun with 75 to 450 International units daily by intramuscular injection for 7 to 10 days; followed by individual adjustments according to the patient's follicular response i.e. until an adequate, but not excessive, response is achieved. The investigator will decide the starting dose according to the standard clinical practice (and within the approved label). Treatment is then stopped and followed after 1 or 2 days by a single dose of human chorionic Gonadotropin 10000 International units to induce oocyte maturation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Patients must be prescribed Follitropin Alfa (Gonapure®)
Alexandria University
Alexandria, Egypt
RECRUITINGAin Shams University
Cairo, Egypt
COMPLETEDNumber of oocytes retrieved on the day of Ovum Pick-Up
Time frame: 50 days after baseline visit (EOS)
Number of Mature Oocytes (MII) Retrieved Per Participant
Metaphase II (MII): The oocyte is in the second phase of meiosis and is mature. Oocytes at this stage of maturity are ready for fertilization. Mean number of Mature oocytes (MII) retrieved on the day of ovum pick up (OPU) will be calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
Time frame: 50 days after baseline visit (EOS)
Quality of Oocytes Retrieved per participant
It is graded on a good-fair-poor scale: * Good * Clear cytoplasm/normal shape * Single distinct polar body * Clear/thin zona pellucida * Fair * Slightly grainy cytoplasm/misshapen * Fragmented/abnormal polar body * Slightly pigmented/amorphous zona * Cytoplasmic bodies * PV (vitelline platelets) debris * Poor * Dark/grainy cytoplasm/misshapen * \>1 polar body structure * Pigmented/thickened zona * Vacuoles * PV (vitelline platelets) debris * Good Quality embryos per participant. Those embryos that have reached the most advanced developmental stage and have the least cellular fragmentation (Grades "A" and/or "B") will be considered Good Quality embryos and will be selected for transfer. * Number of transferred embryos per participant. * Percentage of Participants with Clinical Pregnancy. Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan.
Time frame: 50 days after baseline visit (EOS)
Eventual AE/SAEs related to the administration of Gonapure®
Time frame: 50 days after baseline visit (EOS)
Total & Mean Gonapure ® Daily Dose
Time Frame: Start of treatment until end of stimulation cycle
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 14 days
Number of follicles ≥ 18 mm on day of administration of hCG
Time frame: 50 days after baseline visit (EOS)
Number of Participants with Multiple Pregnancies
Multiple pregnancies were defined as 2 or more fetal hearts with activity.
Time frame: 50 days after baseline visit (EOS)
Number of Participants with Ovarian Hyperstimulation Syndrome
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid Accumulation, hemoconcentration, and increased blood clotting.
Time frame: 50 days after baseline visit (EOS)