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IRCT201107146420N3 IRCT 2011-08-10 shahid sadoughi university of medical science Comparison of letrozole and clomiphen in mild protocol among infertile poor responders Comparison of letrozole and clomiphen in mild protocol among infertile poor responders 2009-01-01 anticipated 200 Complete https://irct.ir/trial/6861 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization by table of random numbers. 2 Infertility. Intervention 1: group I: clomiphen citrate 50 mg twice a day from 3th day of menstruation cycle until 7th day of the cycle. Intervention 2: group II: letrozole 2.5 mg twice a day from 3th of the cycle until 8th day. Abstract Background: Poor ovarian response to controlled ovarian stimulation is one of the most important interest points in assisted reproduction. Mild ovarian stimulation seems to be preferable to high dose of FSH regimens in women with a history of poor ovarian response in previous protocol. Clomiphene citrate and letrozole alone or in combination with FSH have been used in mild ovarian stimulation protocol. Objective: To compare the efficacy of letrozole and clomiphene citrate for mild ovarian stimulation on assisted reproductive technology outcomes in poor responders. Materials and Methods: In a randomized control study, 184 women aged between 20 and 45 years with the history of poor response to ovarian stimulation who were candidate for ART were randomly subdivided into two groups: group I (n= 80), women who underwent the clomiphene/gonadotropin/antagonist protocol; and group II (n= 87), patients who underwent the letrozole/gonadotropin/antagonist protocol. Groups were compared regarding implantation, chemical and clinical pregnancy rates. Results: There was a significant difference in the mean endometrial thickness between two groups (9.16±1.2 mm vs. 8.3±0.3 mm). The implantation rate was significantly higher in letrozole group compare to clomiphene group (7.2 vs. 6.6%, p=0.024 respectively). No significant differences were found in chemical and clinical pregnancy rate between two groups. Conclusion: In mild ovarian stimulation protocol, letrozole and clomiphene have similar value for the poor responder. The optimal treatment strategy for these patients remains debated. Yes - There is a plan to make this available What will be shared: All participant data sets are to be shared When: 2 months after the result publication To whom: A journal in which the results are published Conditions: Submission of an official application via the agent that is legally in charge Where to obtain: Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran How to obtain: 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. Comments:
public Maryam Eftekhar
Safaeiyeh, Bouali Ave
Yazd Iran (Islamic Republic of) 8916977443 +98 35 1824 7085 eftekhar@ssu.ac.ir Research and Clinical Center for Infertility scientific Maryam Eftekhar
Safaeiyeh, Bouali Ave
Yazd Iran (Islamic Republic of) 8916877391 +98 35 1824 7085 eftekhar@ssu.ac.ir Research and Clinical Center for Infertility Iran (Islamic Republic of) three or fewer oocytes were been retrieved in previous failed ART cycle; serum E2 levels ≤ 500 pg/ml on the day of hCG administration. 20 years 45 years Female BMI >30 mg/m2; endocrine or metabolic disorders; history of ovarian surgery; severe endometriosis; azoospermia in male partner. FSH >15 m IU/ml N70-N77 Inflammatory diseases of female pelvic organs Treatment - Drugs Treatment - Drugs group I: clomiphen citrate 50 mg twice a day from 3th day of menstruation cycle until 7th day of the cycle. group II: letrozole 2.5 mg twice a day from 3th of the cycle until 8th day. Chemical pregnancy. Timepoint: 12 day after embryo transfer. Method of measurement: beta hCG blood test. Clinical pregnancy. Timepoint: 3 weeks after chemical pregnancy. Method of measurement: observation of fetal heart activity by transvaginal ultrasonography. Implantation rate. Timepoint: 3 weeks after chemical pregnancy. Method of measurement: the ratio of the number of embryonic sacs diagnosed by sonography to the total number of the embryos transferred. shahid sadoughi university of medical science Approved 2010-10-31 Ethics committee of Yazd Research and Clinical Center for infertility, Shahid Sadoughi University of Bouali Ave, Safaeiyeh Yazd Yazd Iran (Islamic Republic of)