An interventional study of Letrozole 2.5mg tablet in Ovarian Stimulation, sponsored by Menoufia University. Completed at 1 site in Egypt. Open to female participants aged 40 Years to 44 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Menoufia University · Not applicable, Interventional, and Treatment
The aim of this study To compare the clinical and laboratory outcomes of two ovarian stimulation protocols (standard GnRH antagonist protocol and aromatase inhibitor/ antagonist protocol) in women (40-44) years undergoing ICSI cycle.
Fertility is known to decline significantly in women after the age of 35 years, and fecundity is almost completely lost after the age of 45 . As age increases the natural fecundity and pregnancy rates after assisted reproduction decrease .This reduction in fecundity is thought to be due to ovarian aging mainly, which is defined as a decline in both the quantity and quality of the ovarian follicle pool .The increase in patient's age is associated with poor ovarian response, as represented by smaller ovarian volume, lower antral follicle count and poor stromal vascularity. In addition to the reduction in fecundity, there is an increase in spontaneous abortion rates in this group of women .It has been reported that about 19% of all women undergo ART are 40 years, and they could be considered as expected poor responders .Various protocols of ovarian stimulation have been proposed to optimize IVF results in this age group, however, satisfactory results remain a challenge . The lack of initial central down-regulation in early follicular phase and adequate prevention of premature luteinizing hormone (LH) surge in late follicular phase provide GnRH antagonist protocol as a potentially proper option .The use of aromatase inhibitors in a GnRH antagonist protocol was suggested by some studies [Mit. Yarali and colleagues demonstrated that adjuvant therapy with letrozole could improve the response [Yarali et al., 2009]. Meanwhile, in another study, adding letrozole to ovarian stimulation has no positive effect on the likelihood of pregnancy . Letrozole is a selective, non-steroidal third generation aromatase inhibitor. Letrozole causes a reduction in conversion of androstenedione and testosterone to estrone and estradiol by inhibiting the aromatase enzyme activity . According to some published studies, the decline in early follicular phase estrogen levels, and consequently decrease in negative feedback of estrogen on FSH release in hypothalamic-pituitary axis cause an increase in endogenous gonadotropin secretion and stimulation of ovarian follicular growth. In addition, an increase in intraovarian androgens secondary to aromatase inhibition, augments the follicular sensitivity to FSH stimulation and follicular growth . Letrozole has no antiestrogenic effect over the endometrium . These reports prompted us to hypothesize that use of letrozole as a co-treatment agent in GnRH antagonist protocol might enhance cycle outcomes.
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Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Gonadotropins (300-450 IU) IM start on cycle day 2 then the dose modulated according to response
Drug: Letrozole 2.5mg tablet
letrozole orally in a dose of 2.5 mg daily, on day 2 of cycle for 5 days and gonadotropins (300-450 IU) IM start on cycle day 3. then the dose modulated according to response
Drug: Letrozole 2.5mg tablet
letrozole (femara, Novartis) orally in a dose of 2.5 mg daily, on day 2 of cycle for 5 days and gonadotropins (300-450 IU) IM start on cycle day 3. then the dose modulated according to response
Also known as: Gonadotropins units
live birth rate
deliveries ≥22 weeks gestation with heartbeat and breath
Time frame: 1 year after embryo transfer
positive hCG
serum β-hCG ≥10 mIU/mL
Time frame: 2 weeks after FET
clinical pregnancy
presence of intrauterine gestational sac by trans-vaginal ultrasound at gestational weeks.
Time frame: 5 weeks' gestation
Total gonadotropin /cycle (IU),
number of gonadotropin units needed per cycle
Time frame: two weeks
Duration of stimulation (Day),
number of days needed for stimulation
Time frame: two weeks
Endometrial thickness (mm)
measure endometrial thickness
Time frame: two weeks
serum E2 levels
measuring E2 level during stimulation
Time frame: two weeks
Follicles number
number of follicles during stimulation
Time frame: two weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Menoufia University