Infertility Clinical Trial
Official title:
Extended High Dose Letrozole Regimen Versus Short Low Dose Letrozole Regimen as an Adjuvant to GnRH Antagonist Protocol in the Management of Patients With Poor Ovarian Response Undergoing IVF-ET, a Randomized Controlled Trial
The aim of this randomized controlled trial is to compare the efficacy of extended high dose letrozole regimen (5 mg /day for the first 5 days of cycle and 2.5 mg/day for the subsequent 3 days ) with short low dose letrozole regimen (2,5 mg/day from cycle day 3 to 7 ) as an adjuvant to GnRH antagonist protocol in the management of patients with poor ovarian response undergoing IVF-ET.
Poor response to controlled ovarian stimulation (COH) is estimated to occur in 9-24 % of all
IVF cycles. Although there is no consensus on the definition of poor response to COH,
inability to produce adequate number of mature follicles( ≤ 2-5) or to recruit adequate
number of oocytes ( ≤ 3 oocytes ) in response to standard stimulation protocols are the main
criteria used for diagnosis of poor responders .
Patients with poor response to COH usually have higher cyclical cancelation rate , poor
embryo quality and less number of embryos suitable for transfer or cryopreservation .
During the past decade gonadotropin releasing hormone antagonists (GnRHant) were widely used
in the treatment of patients with poor response to standard gonadotropin releasing hormone
agonist (GnRHa) protocols .In contrast to GnRHa, GnRHant is administered at the late
follicular phase and therefore don't suppress the early follicular phase endogenous
gonadotropins and has no suppressive effect on ovarian function at the stage of follicular
recruitment.Several studies comparing GnRHant protocol with the standard GnRHa long protocol
revealed a reduction in the duration of stimulation , dose of required gonadotropins , and
the costs of IVF cycle with GnRHant as well as equivalent pregnancy rates .
In 2001, Mitwally and Casper introduced letrozole ( a third generation non steroidal
aromatase inhibitor licensed for treatment of hormonally-responsive breast cancer after
surgery ) as new ovulation induction agent in clomiphene citrate resistant patients with
polycystic ovary syndrome (PCOS) . Subsequent studies confirmed the effectiveness of
letrozole in induction of ovulation in women with PCOS and in superovulation (either alone
or in combination with gonadotropins ) .
In patients with poor response undergoing IVF, several studies revealed that the combination
of letrozole ( 2.5 mg or 5 mg/day for 5 consecutive days in early follicular phase ) with
GnRHant protocol improved the ovarian response and reduced the gonadotrophin dose required.
On the other hand , Schoolcraft et al reported that letrozole(2.5 mg/day from cycle day 3 to
7)/GnRHant protocol has no advantages over microdose flare GnRHa protocol.
The ideal dose and duration of letrozole administration for ovulation and superovulation is
still not clear. Several studies comparing two doses of letrozole (2.5 mg or 5 mg) in
superovulation suggested that the higher dose might be associated with more follicles
developing.
In almost all studies to date , letrozole was administered for five consecutive days in
early follicular phase . In only one study , letrozole (2.5 mg/day) was administered for ten
consecutive days starting on day 1 of menstrual cycle . In that study , prolonged
administration of letrozole produced more mature follicles and pregnancies than short
letrozole therapy regimen in patients with clomiphene citrate resistant polycystic ovary
syndrome .
The investigators designed this randomized controlled trial to compare the efficacy of
extended high dose letrozole regimen (5 mg /day for the first 5 days of cycle and 2.5 mg/day
for the subsequent 3 days ) with conventional short low dose letrozole regimen (2,5 mg/day
from cycle day 3 to 7 ) as an adjuvant to GnRHant protocol in the management of patients
with poor ovarian response undergoing IVF-ET.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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