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IRCT20211211053355N1 IRCT 2022-01-09 Yazd University of Medical Sciences Evaluation sperm selection technique on embryo development and pregnancy outcomes Evaluation the efficiency of human sperm DNA fragmentation test, telomere assay and sperm selection technique on embryo development and pregnancy outcome. 2022-01-21 anticipated 100 Complete https://irct.ir/trial/60608 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization with quadruple blocks, the blocks are arranged as follows: Block1: ABAB, Block2: AABB، Block 3: ABBA، Block 4: BBAA, Block5: BABA، Block 6: BAAB. 25 blocks will be required to select 100 participants with male factor infertility. These blocks will be selected randomly from 1-6 by software. For example after selection block 2: The first two participants will be dedicated to ICSI group and the second two participants will be dedicated to IMSI group, Blinding description: In this study participants and embryologists will not be informed that sperm selection will be done by ICSI or MSOME. At the first, sperm selection will be done by investigator under magnification 400 of inverted microscope for ICSI group and magnification more than 6600 for IMSI group, then sperms will be loaded in a drop of ICSI dish. Finally microinjection will be done by embryologist. Investigator is an embryologist and will not do microinjection. Investigator will explained about two techniques of sperm selections. N/A Male factor infertility with characterized by Teratozoospermia. Intervention 1: Intervention group: Intracytoplasmic Morphologic Examination Sperm Injection (IMSI). In this group, researcher will be selected sperms under inverted microscope with more than 6000x magnification. Intervention 2: Control group: Intracytoplasmic Sperm Injection(ICSI). In this group, researcher will be selected sperms under inverted microscope with 400x magnification. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule has not yet been determined
public Fatemeh Shakeri
Yazd Infertility Center, Bou Ali st, Timsar Fallahi,
Yazd Iran (Islamic Republic of) 8916877391 38247085 Fatemehshakeri1359@yahoo.com Yazd University of Medical Sciences scientific Azam Agharahimi
Yazd Infertility Center, Bou Ali st, Timsar Fallahi st
Yazd Iran (Islamic Republic of) 8916877391 38247085 63rahimi@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Male participants are characterized by fresh ejaculated spermatozoa with a concentration of at least 5 million/ml , Teratozospermia and having indication for ICSI because of male infertility. female partners aged under 38 years old, without poor ovarian response and having day 3 serum FSH < 15 IU/lit will be entered the study no limit no limit Male Testicular samples and ejaculate samples with concentration below 5 million / ml ّfemale partner with poor ovarian response, endometriosis, and cases with no embryo to transfer. N46.8 Male Infertility Early detection Treatment - Other Intervention group: Intracytoplasmic Morphologic Examination Sperm Injection (IMSI). In this group, researcher will be selected sperms under inverted microscope with more than 6000x magnification. Control group: Intracytoplasmic Sperm Injection(ICSI). In this group, researcher will be selected sperms under inverted microscope with 400x magnification. Embryo development. Timepoint: 3 days after microinjection. Method of measurement: Based on Hill's grading. Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: Evaluation of B HCG in blood serum. Clinical Pregnancy. Timepoint: 8 weeks after embryo transfer. Method of measurement: detection of embryo heart beat in abdominal sonography. Fertilization Rate. Timepoint: 16-18 hours after microinjection. Method of measurement: evaluation the formation of 2 pronucleous under the microscope. Embryo implantation rate. Timepoint: 6weeks after embryo transfer. Method of measurement: detection the number of gestational sac in abdominal sonography. Evaluation SDF and STL in sperms with scores between 0-6. Timepoint: Before randomization. Method of measurement: Sperm DNA fragmentation test, Sperm Telomere Assay. Yazd University of Medical Sciences Approved 2021-12-08 Ethics research of Yazd University of Medical Sciences Yazd Infertility Center, Bou Ali st, Timsar Fallahi st, Safaieyeh Yazd Yazd Iran (Islamic Republic of)