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IRCT20110509006420N19 IRCT 2018-09-18 Yazd University of Medical Sciences Letrozole in assisted reproductive techniques protocol The effect of adding letrozole to gonadotropin on pregnancy outcomes in patients who are the candidate for assisted reproductive techniques 2018-08-01 anticipated 100 Complete https://irct.ir/trial/33018 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using computer-generated random numbers in wrapped, unlabeled envelope each holding a unique number. 2 female Infertility. Intervention 1: Control group: Antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done. Intervention 2: Intervention group: antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously, all patients in this group will receive 5 mg letrozole (Iran hormone-Iran)) orally science send day of cycle, When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done. 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the privacy of patients
public Maryam Eftekhar
Bouali
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 eftekharmaryam@yahoo.com Yazd University of Medical Sciences scientific Maryam Eftekhar
Bouali
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 eftekharmaryam@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Patients referred to the Infertility Center, which is undergoing ovulation induction for assisted reproductive techniques. normal ovarian reserve 18 years 40 years Female History of endocrine disorders Intrauterine abnormality (uterine polyp & sub mucosal fibroma & intrauterine adhesions) Azoospermia of partner Severe endometriosis N97.9 Female infertility, unspecified Treatment - Drugs Treatment - Drugs Control group: Antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done. Intervention group: antagonist group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously, all patients in this group will receive 5 mg letrozole (Iran hormone-Iran)) orally science send day of cycle, When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done. Chemical pregnancy. Timepoint: 15 days after embryo transfer. Method of measurement: Blood laboratory kit. Clinical pregnancy. Timepoint: 3 weeks after positive beta-h Cg. Method of measurement: Observation of fetal heart activity by transvaginal ultrasonography. Yazd University of Medical Sciences Approved 2018-06-20 Ethic commitee of Yazd research center for infertility-Shahid Sadoughi University of Medical Scienc Bouali Yazd Yazd Iran (Islamic Republic of)