Female Infertility Clinical Trial
Official title:
An Interventional Study to Assess the Efficacy and Safety of Gonapure® in Multifollicular Stimulation in Egyptian Women Undergoing IVF/ICSI
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.
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