Infertility Clinical Trial
Official title:
Protocol to Minimize Injections and Blood Draws for Women Undergoing Controlled Ovarian Hyperstimulation for in Vitro Fertilization
The purpose of the study is to evaluate the safety and efficacy of nasal gonadotropins (Menopur) in women undergoing IVF. The purpose of this study is also to report and monitor any and all side effects of the nasal Menopur.
Gonadotropins are used during fertility treatments such as intrauterine insemination (IUI) or
in vitro fertilization (IVF). These fertility medications are given by injection that contain
follicle-stimulating hormone (FSH) alone or combined with luteinizing hormone (LH). During a
regularly occurring menstrual cycle, both FSH and LH are produced by the pituitary gland in
the brain to naturally stimulate the ovaries to make a single egg each month. When FSH and/or
LH are given as an injection as fertility treatment, they work directly on the ovaries to
make multiple follicles which are cysts containing the eggs.
Injections of gonadotropins are started early (usually on the third day) in the menstrual
cycle to cause multiple eggs to grow to a mature size. Close monitoring of patients with
ultrasound and blood are usually needed for monitoring. The ultrasound measures the size of
the ovarian follicles. Blood is usually drawn every other day or daily (for a total of 12
days on average) for measurement of Estradiol (E2), progesterone (P4), and luteinizing
hormone (LH). The measurement of E2, P4 and LH is intended to quantify the response of the
ovaries to the daily injectable gonadotropins. When the follicles grow to a large size
(usually 18 mm), human chorionic gonadotropin (hCG), another injectable medication, is then
used to trigger the maturity of the eggs before performing egg retrieval during an IVF cycle.
Instead of injectable gonadotropins, this study uses nasal gonadotropins (Menopur) in order
to evaluate its safety and efficacy of in women undergoing IVF.
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