The effect of adding letrozole to gonadotropin on pregnancy outcomes in patients who are the candidate for assisted reproductive techniques

Effect of adding letrozole to gonadotropin on pregnancy outcomes

Clinical trials, sample size 100 patients, phase 3 of the clinical trial, with the control group, with parallel groups, without blindness, randomized with an enveloped packet.

This Randomized clinical trial without blindness is conducted for evaluating the effect of intrauterine injection of PRP in Asherman patients referred to Shahid Sadoughi Hospital or Research and Clinical Center for Infertility, Yazd, Iran.

Inclusion criteria: Infertile patients which are the candidate for ART. Exclusion criteria: History of endocrine disorders, Intrauterine abnormality (uterine polyp & submucosal fibroma & intrauterine adhesions), Azoospermia of partner Severe endometriosis

Intervention group: since the second day of the cycle all patients Will receive 150 unit gonadotropin, all patients in this group will receive 5 mg letrozole orally science the second day of the cycle When dominant follicle reached to 12-13 mm, antagonist.25 mg will be injected daily subcutaneously. when dominant follicle reaches 17 mm, final triggering will be done. Control group: since the second day of the cycle all patients Will receive 150 unit gonadotropin, When the dominant follicle reached 12-13 mm, antagonist.25 mg will be injected daily subcutaneously. when dominant follicle reaches 17 mm, final triggering will be done.

Chemical pregnancy rate, clinical pregnancy rate

Updating the trial according to the last changes in methods and adding results

Using computer-generated random numbers in wrapped, unlabeled envelope each holding a unique number.

Due to the privacy of patients

The study protocol, the statistical analysis map, the clinical study report will be available after the publishing of the article.

After publishing the article

Researchers working in academic institutions

use in the retrospective study

use in the retrospective study

Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.

Abstract Background Aromatase inhibitors prevent the aromatization of androgens into estrogens, which reduces the negative feedback of estrogen on the hypothalamic-pituitary axis. It is clear that increasing the secretion of follicle-stimulating hormones results in an increased follicular growth. Objective This study aimed to evaluate the effect of adding letrozole to gonadotropin on in vitro fertilization outcomes in normal responders. Materials and Methods In this randomized clinical trial, 100 normal responder women candidate for controlled ovarian stimulation were randomly enrolled in two groups (n = 50/each). In the case group letrozole was added to gonadotropin in the antagonist protocol. The control group received the conventional antagonist protocol. The main outcome was clinical and chemical pregnancy; and the second outcomes were the number of mature oocytes, the fertilization rate, estradiol level, and the total dose of gonadotropins. Results Basic clinical and demographic features were comparable between the groups. Estradiol level on the day of human-chorionic-gonadotropin administration and the total gonadotropin consumption were significantly higher in the control group than the case group (p = 0.045). In addition, the number of MII oocytes was higher (but not significantl) in the case group than the control group (p = 0.09). Moreover, the endometrial thickness was significantly lower in the case group. There were no significant differences in fertilization rate and chemical and clinical pregnancy rates between the two groups. Conclusion Although adding letrozole to gonadotropin in normal responders reduces the total dose of gonadotropin, it does not improve the pregnancy outcomes.