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IRCT20220104053629N1 IRCT 2022-02-13 Yazd University of Medical Sciences Effect of adding long-acting GnRH agonist plus Letrozole to frozen embryo transfer cycles Effect of adding long-acting GnRH agonist plus Letrozole to endometrial preparation method with Estradiol on pregnancy outcome in frozen embryo transfer cycles among women with recurrent implantation failure: A clinical trial 2022-02-19 anticipated 64 Complete https://irct.ir/trial/61168 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of samples in the two groups will be done using permutation block method using Random allocation 1 software. 8 blocks with a size of 8 samples are considered. For allocation concealment, sealed envelopes for each person is used. 3 Female infertility. Intervention 1: Control group: This group just receive 6 mg of Estradiol valerate daily from the second day of the menstrual cycle. Transvaginal sonography is performed on day 13 of the menstrual cycle, and after reaching an endometrial thickness of at least 7 mm, 400 mg of vaginal Progesterone twice daily with 6 mg of estradiol daily for three days until the day of embryo transfer will consume. Intervention 2: Intervention group: Patients in the case group will receive a monthly dose of Triptorelin 3.75 for up to two months plus 5 mg of Letrozole daily, and immediately after the end of two months of treatment they will enter the freeze embryo transfer cycle and start taking 6 mg of estradiol daily. Transvaginal sonography is performed on day 13 of the menstrual cycle, and after reaching an endometrial thickness of at least 7 mm, 400 mg of vaginal Progesterone twice daily with 6 mg of estradiol daily for three days until the day of embryo transfer will consume. 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. yazd-rsi@ssu.ac.ir 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 Razieh Dehghani Firoozabadi
Bouali Ave, Safaeyeh
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 Firouzabadirazieh@gmail.com Yazd University of Medical Sciences scientific Razieh Dehghani Firoozabadi
Bouali Ave, Safaeyeh
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 Firouzabadirazieh@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) 18 to 42 years old infertile women The history of at least two implantation failure of good quality embryos (A and B) Frozen thawed embryo transfer cycle Candidate for embryo transfer with A and B grade 18 years 42 years Female Severe male factor or sperm retrieval except ejaculation Endometriosis in previous sonography or laparascopy Severe adenomiosis in sonography History of myoma surgery or any interfering myoma with implantatio History of implantation failure because of thin endometrium N97 Female infertility Treatment - Drugs Treatment - Drugs Control group: This group just receive 6 mg of Estradiol valerate daily from the second day of the menstrual cycle. Transvaginal sonography is performed on day 13 of the menstrual cycle, and after reaching an endometrial thickness of at least 7 mm, 400 mg of vaginal Progesterone twice daily with 6 mg of estradiol daily for three days until the day of embryo transfer will consume. Intervention group: Patients in the case group will receive a monthly dose of Triptorelin 3.75 for up to two months plus 5 mg of Letrozole daily, and immediately after the end of two months of treatment they will enter the freeze embryo transfer cycle and start taking 6 mg of estradiol daily. Transvaginal sonography is performed on day 13 of the menstrual cycle, and after reaching an endometrial thickness of at least 7 mm, 400 mg of vaginal Progesterone twice daily with 6 mg of estradiol daily for three days until the day of embryo transfer will consume. Rate of chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: pregnancy blood test. Rate of clinical pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: Seeing gestational sac in sonography. Rate of chemical abortion. Timepoint: 4 weeks after embryo transfer. Method of measurement: Positive pregnancy blood test without gestational sac. Yazd University of Medical Sciences Approved 2021-12-19 Ethics committee of Yazd Reproductive Institute, Shahid Sadoughi University of medical sciences Bouali Ave, Safaeiyeh Yazd Yazd Iran (Islamic Republic of)