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IRCT20110509006420N27 IRCT 2024-01-27 Yazd University of Medical Sciences Comparison of the effect of tow embryo transfer in the stage of blastocyst and sequential transfer of a cleavage-a blastocyst embryo on pregnancy outcomes Patients who are candidates for frozen embryo transfer and recurrent implantation failure; a randomized clinical trial Comparison of the effect of tow embryo transfer in the stage of blastocyst and sequential transfer of a cleavage-a blastocyst embryo on pregnancy outcomes Patients who are candidates for frozen embryo transfer and recurrent implantation failure; a randomized clinical trial 2024-01-30 anticipated 140 Complete https://irct.ir/trial/74744 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, using the simple randomization method using the Random Allocation1 software (http://random-allocation software.informer.com\1) and based on the simple randomization method, the list of samples in the two groups studied by the expert Statistics will be generated. In this software, in order to generate a list of random numbers, first specify the number of groups to be studied as 2 and the total number of samples required as 140 people, and then from the list of sample randomization methods, the method (simple randomization method in parallel group) by considering the same number of samples in the groups. Then a random list will be generated based on the groups and the number of samples in each group. Randomly and after obtaining informed consent by the researcher, they are assigned to two groups. The sealed envelope method is used for concealment. Then a random list will be generated based on the number of samples in each group. 3 Infertility. Intervention 1: Intervention group: Infertile people who are candidates for frozen embryo transfer with a history of two implantation failures, if their number of embryos is at least 4, after obtaining a written consent, embryo transfer will be done for them consecutively. In this way, in the first stage, an embryo is cleaved and two to three days after the transfer of the first embryo, the transfer of the second embryo is done in the form of a blast. Intervention 2: Control group: Infertile candidates for frozen embryo transfer with a history of twice implantation failure, if their number of embryos is at least 4, after obtaining a written consent, they will undergo embryo transfer in one step. In this way, two blastocyst embryos will be transferred to them at the same time. 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: In order to receive data or other study documents, researchers working in academic and scientific institutions are allowed to apply Conditions: To evaluate the accuracy of the data and use data to complete other researches 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
Yazd Reproductive Sciences Institute, BouAl Ave., Safaeih
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 eftekhar@ssu.ac.ir Yazd University of Medical Sciences scientific Maryam Eftekhar
Yazd Reproductive Sciences Institute, BouAl Ave., Safaeih
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 eftekhar@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Candidates for frozen embryo transfer Failure of more than 2 implants The number of frozen embryos is at least four Women under the age of 45 no limit 45 years Female Uncontrolled endocrine diseases (diabetes, hyperthyroid and hypothyroid) Egg donation Uncontrolled autoimmune diseases (lupus and rheumatoid arthritis) Severe uterine adenomyosis Sever Asherman Untreated hydrosalpinx N97 Female infertility Treatment - Other Treatment - Other Intervention group: Infertile people who are candidates for frozen embryo transfer with a history of two implantation failures, if their number of embryos is at least 4, after obtaining a written consent, embryo transfer will be done for them consecutively. In this way, in the first stage, an embryo is cleaved and two to three days after the transfer of the first embryo, the transfer of the second embryo is done in the form of a blast. Control group: Infertile candidates for frozen embryo transfer with a history of twice implantation failure, if their number of embryos is at least 4, after obtaining a written consent, they will undergo embryo transfer in one step. In this way, two blastocyst embryos will be transferred to them at the same time. Clinical pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: Sonography. Chemical pregnancy. Timepoint: Two weeks after embryo transfer. Method of measurement: Through the measurement of BHCG. Twin pregnancy. Timepoint: In the 6th week of pregnancy. Method of measurement: Observation of two gestational sacs in vaginal ultrasound. The rate of premature abortion. Timepoint: Ten weeks after embryo transfer. Method of measurement: Absence of fetal heartbeat in sonography. Ectopic pregnancy. Timepoint: After proving chemical pregnancy. Method of measurement: Not increasing beta hCG titer and not seeing pregnancy sac in vaginal ultrasound. Yazd University of Medical Sciences Approved 2024-01-10 Ethics committee of Yazd reproductive Sience Institute- Shahid Sadoghi University of Medical Science Yazd Reproductive Sciences Institute, BouAl Ave., Safaeih, Yazd Yazd Yazd Iran (Islamic Republic of)