J Assist Reprod Genet. 2008 Apr 19 [Epub ahead of print]

Comparison of the efficacy of the aromatase inhibitor letrozole and clomiphene citrate gonadotropins in controlled ovarian hyperstimulation: a prospective, simply randomized, clinical trial.


Sh Tehrani Nejad E, Abediasl Z, Rashidi BH, Azimi Nekoo E, Shariat M, Amirchaghmaghi E.



Vali-e-Asr Reproductive Health Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran, tehraninejad@royaninstitute.org.


Objective:

To study the efficacy of the aromatase inhibitor letrozole in controlled ovarian hyperstimulation (COH). MATERIAL AND

Methods:

In this prospective simply randomized clinical trial, one hundred forty patients with unexplained infertility undergoing intrauterine insemination (IUI) therapy were randomized to receive either letrozole or clomiphene citrate (CC)-gonadotropin. The patients were selected among patients referred to one university hospital and one private infertility clinic. A letrozole dose of 5 mg/day (n = 70) was given on days 3-7 of the menstrual cycles. Clomiphen citrate a dose of 100 mg/day was given like letrozole but combined with human menopausal gonadotropin (hMG) dose of 75 IU/ml administered every day starting on day 6. Ovulation was triggered with urinary hCG (10,000 IU) when the leading follicle(s) reached 18 mm in diameter. A single IUI was performed 36 hours later. The luteal phase was supplemented with micronized progesterone vaginally. Ovarian stimulation response (E2 levels and number of follicles) was primary outcome.

Results:

There were no differences in demographic characteristics between groups. The number of mature follicles (1.8 +/- 0.7 vs. 2.46 +/- 2.3; P = 0.042) and serum E2 level on the day of hCG (310 +/- 135.4 vs. 1,670.7 +/- 1021.8 pg/ml, respectively; P < 0.0001) were significantly lower in letrozole group. A significantly higher endometrial thickness was observed at the time of hCG administration in patients that received letrozole (9.7 +/- 1.6 mm vs. 7.8 +/- 2 mm; P < 0.001).Clinical pregnancy rates also were significantly higher in letrozole group (32.8% vs. 14.3%, respectively; P < 0.01).

Conclusion:

The aromatase inhibitor letrozole appears to constitute a good alternative to CC-gonadotropin in patients with unexplained infertility undergoing COH cycles combined with IUI therapy.


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