The aim of this study is to evaluate the role of low dose injectable progesterone in triggering ovulation.
Infertility affects approximately 10-15% of couples attempting pregnancy, with no readily identifiable cause found in 15-30% of these patients, resulting in a diagnosis of unexplained infertility. Kol and Itskovitz-Eldor stated that when using GnRH agonist to trigger ovulation in IVF cycles, the LH surge is associated with a rapid rise of progesterone and the attainment of peak E2 levels through the first 12 h after GnRH agonist administration which is followed by a temporary suppression of progesterone biosynthesis and a gradual drop in E2 levels during the 24 h before follicle aspiration. After oocyte retrieval, a second rise in progesterone and continuous fall in E2 are noted, reflecting transitions from follicular to luteal phase in ovarian steroidogenesis. Letrozole (LE) is a nonsteroidal, highly selective oral aromatase inhibitor (AI) that inhibits the synthesis of oestrogen and increases the secretion of endogenous gonadotropin by diminishing negative feedback to stimulate ovulation. Currently, letrozole is widely used as an adjunct for IVF cycles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Women will receive low dose progesterone 5 mg intramuscularly as a study group. (Letrozole 2.5 mg/day will be given from cycle day 3 onwards for only 5 days).
Women will receive placebo as a control group. (Placebo 2.5 mg/day will be given from cycle day 3 onwards for only 5 days).
Teaching Hospitals and Institutes
Cairo, Egypt
RECRUITINGIncidence of ovulation rates
Incidence of ovulation rates will be recorded.
Time frame: 10-12 days of the menstrual cycle
Follicle stimulating hormone (FSH)levels
Follicle stimulating hormone (FSH) will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval.
Time frame: 10-12 days of the menstrual cycle
Luteinizing hormone (LH)levels
Luteinizing hormone (LH) will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval).
Time frame: 10-12 days of the menstrual cycle
Estradiol (E2) levels
Estradiol (E2) will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval.
Time frame: 10-12 days of the menstrual cycle
Progesterone levels
Progesterone levels will be measured on day 3, day 8-10 and day 10-12 of the menstrual cycle, as well as the day of trigger and oocyte retrieval.
Time frame: 10-12 days of the menstrual cycle
Number of oocytes
Number of oocytes will be recorded. Ovulation monitoring will be done from the last day of the cycle until ovulation occurs approximately in the middle of the cycle.
Time frame: 8 days of the menstrual cycle
Mature oocytes
Mature oocytes will be recorded.
Time frame: 16 days of the menstrual cycle
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Clinical pregnancy rate.
Clinical pregnancy rate will be recorded.
Time frame: One week late from the previous menstrual cycle
Biochemical pregnancy
Biochemical pregnancy will be recorded through a blood pregnancy test on the date of the next menstrual period
Time frame: 16 days of the menstrual cycle
Early miscarriage rate
Early miscarriage rate will be recorded.
Time frame: 16 days of the menstrual cycle