Infertility Clinical Trial
Official title:
Extended Letrozole Regimen Versus Clomiphene Citrate for Superovulation in Patients With Unexplained Infertility Undergoing Intrauterine Insemination
The aim of this randomized controlled trial is to compare the efficacy of extended letrozole regimen (2.5mg/day from cycle day 1 to 9) with clomiphene citrate (100 mg/day from cycle day 3 to 7) in women with unexplained infertility undergoing superovulation and intrauterine insemination .
Unexplained infertility is one of the most frequent infertility diagnoses encountered by the
gynaecologists . Several studies reported that 10 to 20% of infertile couples have
unexplained infertility .
Superovulation and intrauterine insemination (IUI) is an effective treatment for couples
with unexplained infertility . Superovulation increases the probability of pregnancy by
increasing the number of oocytes suitable for fertilization or by correcting any subtle
defect in ovulation . Furthermore, IUI increases the concentration of active motile sperms
reaching the fallopian tube and overcomes male factors or cervical factors of infertility
not detected by conventional tests .
For more than four decades , clomiphene citrate has been the first line therapy used for
induction of ovulation in women with anovulatory infertility and for superovulation in
couples with unexplained infertility, mild endometriosis and mild male factor of infertility
. Clomiphene citrate is cheap , orally administered , requires no frequent monitoring and
associated with very low risk of high-order multiple gestation and severe ovarian
hyperstimulation syndrome . However , clomiphene citrate causes long lasting depletion of
estrogen receptors and therefore exerts antiestrogenic effect on estrogen target tissues as
endocervical mucosa and endometrium .Several studies revealed the clomiphene citrate has a
deleterious effect on cervical mucous quantity and quality and endometrial development
resulting in endometrial thinning , luteal phase defect ,decreased uterine flow and
implantation failure .
During the past decade, letrozole (aromatase inhibitor approved by FDA for the treatment of
postmenopausal women with breast cancer ) has been successfully used in induction of
ovulation in anovulatory patients with polycystic ovary syndrome and in augmentation of
ovulation in ovulatory women . In contrast to clomiphene citrate , letrozole is rapidly
eliminated from the body and does not deplete estrogen receptors and therefore has no
antiestrogenic effects on endometrium or endocervical mucosa .
Several studies revealed that letrozole can be used as an alternative to clomiphene citrate
for superovulation in patients with unexplained infertility . A metaanalysis of seven
randomized controlled trials comparing aromatase inhibitors ( letrozole or anastrozole )
with clomiphene citrate in patients with unexplained infertility revealed that the pregnancy
rate was comparable between both management options .
The optimal dose and duration of letrozole administration for superovulation in patients
with unexplained infertility is still not clear. In various studies reporting the use of
letrozole for the superovulation , letrozole was administrated from cycle 3 to 7 with daily
dose ranging from 2.5 to 7.5 mg .In a randomized controlled trial , AI-Fadhli et al reported
that the pregnancy rate was significantly higher in patients with unexplained infertility
treated with 5 mg compared to those treated with 2.5 mg . On the other hand, a randomized
controlled trial comparing three doses of letrozole (2.5,5,7.5 mg/day)in the management of
patients with unexplained infertility revealed that the pregnancy rates were comparable
between the three groups .
The aim of this randomized controlled trial is to compare the efficacy of extended letrozole
regimen (2.5mg/day from cycle day 1 to 9) with clomiphene citrate (100 mg/day from cycle day
3 to 7) in women with unexplained infertility undergoing superovulation and intrauterine
insemination .
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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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