Clinical Trial Protocol Iranian Registry of Clinical Trials 27 Sep 2021 Evaluation of laser assisted zona hatching on live birth rate in patients undergoing their first ICSI cycles Protocol summary [email protected] Summary Recruitment status Recruitment complete Objective: Our main goal is to evaluate the effect of laser Funding source assisted hatching (LAH) on delivery rate as well as Investigator congenital anomaly in patients undergoing their first ICSI cycle. Design: Prospective randomized study. Setting: University affiliated infertility center. Participants Expected recruitment start date including major eligibility criteria: About 183 patients will 2009-03-01, 1387/12/11 be subjected to ICSI. All the patients will be infertile due Expected recruitment end date to male factor infertility. Intervention(s): The patients are 2010-04-01, 1389/01/12 randomized into two groups of A (LAH) and B (control, no Actual recruitment start date AH). LAH and embryo transfer are done on day 2. Main empty Outcome Measure(s): Clinical pregnancy, live birth rate, Actual recruitment end date multiple pregnancy, congenital anomaly. empty Trial completion date empty General information Scientific title Acronym Evaluation of laser assisted zona hatching on live birth IRCT registration information rate in patients undergoing their first ICSI cycles IRCT registration number: IRCT2013010310415N2 Registration date: 2013-01-27, 1391/11/08 Public title Registration timing: retrospective routine use of laser assisted embryo hatching and live birth Purpose Last update: Treatment Update count: 0 Inclusion/Exclusion criteria Registration date Inclusion criteria are infertile couples undergoing their 2013-01-27, 1391/11/08 first ICSI due to male factor infertility. Exclusion criteria are female factor infertility; egg donation cases; Registrant information surrogacy; in vitro maturation cycles; conventional IVF Name cycles; frozen thawed spermatozoa; frozen-thawed Nasim Tabibnejad embryos; non-ejaculated spermatozoa; history of Name of organization / entity recurrent abortion or stillbirth as well as history of IVF Yazd Reproductive Sciences Institute, Shahid failure. Sadoughi University of Medical Sciences Age Country No age limit Iran (Islamic Republic of) Gender Phone Female +98 35 1824 7085 Email address Phase 1 2-3 patients Groups that have been masked No information Secondary outcomes Sample size Target sample size: 183 Randomization (investigator's opinion) 1 Randomized Description Randomization description clinical pregnancy rate Blinding (investigator's opinion) Timepoint Not blinded after four weeks Blinding description Method of measurement Placebo clinical pregnancy was determined by gestational sac Not used visualization with aid of ultrasonography or by fetal heart Assignment beat detection Parallel Other design features Intervention groups Secondary Ids 1 empty Description Ethics committees On day two, before embryo transfer, laser zona assisted hatching will be done on embryos in intervention group with the aim of 1480nm wavelength laser for 605 micro 1 second duration to open a hole in ZP (about 10-12 µm). Ethics committee The embryos in control group remained intact and will be Name of ethics committee transferred into the uterine with no laser assisted Ethic committee of Shahid Sadoughi University of hatching. Medical Sciences Category Street address Treatment - Other 89168-77391, Research and Clinical Center for Infertility, Bou-Ali ave., Safayeh 2 City Yazd Description Postal code The embryos in control group (no treatment) remained 89168-77391 intact and will be transferred into the uterine with no Approval date laser assisted hatching. 2013-01-16, 1391/10/27 Category Ethics committee reference number Treatment - Other 2459 Recruitment centers Health conditions studied 1 1 Recruitment center Description of health condition studied Name of recruitment center Female infertility associated with male factors Research and Clinical Center for Infertility ICD-10 code Full name of responsible person N97.4 Mohammad Hossein Razi ICD-10 code description Street address Female infertility associated with male factors 89168-77391, Research and Clinical Center for Infertility, Bou-Ali ave., Safayeh Primary outcomes City Yazd 1 Sponsors / Funding sources Description live birth rate 1 Timepoint about 9 months after embryo transfer Sponsor Method of measurement Name of organization / entity by referring the patients for delivery or by contact to the Investigator 2 Full name of responsible person Iman Halvaei Investigator Position Street address PhD candidate in Reprod Biol 89168-77391, Research and Clinical Center for Other areas of specialty/work Infertility, Bou-Ali ave., Safayeh Street address City 89168-77391, Research and Clinical Center for Yazd Infertility, Bou-Ali ave., Safayeh Grant name City Grant code / Reference number Yazd Is the source of funding the same sponsor Postal code organization/entity? Phone Yes +98 35 1824 7085 Title of funding source Fax Investigator Email Proportion provided by this source [email protected] 100 Web page address Public or private sector empty Person responsible for updating data Domestic or foreign origin empty Contact Category of foreign source of funding Name of organization / entity empty Research and Clinical Center for Infertility, Shahid Country of origin Sadoughi University of Medical Sciences Type of organization providing the funding Full name of responsible person empty Iman Halvaei Position Person responsible for general inquiries PhD can. in Reprod Biol Other areas of specialty/work Contact Street address Name of organization / entity 89168-77391, Research and Clinical Center for Research and Clinical Center for Infertility, Shahid Infertility, Bou-Ali ave., Safayeh Sadoughi University of Medical Sciences City Full name of responsible person Yazd Iman Halvaei Postal code Position 89168-77391 PhD candidate in Reprod Biol Phone Other areas of specialty/work +98 35 1824 7085 Street address Fax 89168-77391, Research and Clinical Center for Email Infertility, Bou-Ali ave., Safayeh [email protected] City Web page address Yazd Postal code Phone Sharing plan +98 35 1824 7085 Deidentified Individual Participant Data Set (IPD) Fax empty Email Study Protocol [email protected] empty Web page address Statistical Analysis Plan empty Person responsible for scientific Informed Consent Form inquiries empty Clinical Study Report Contact empty Name of organization / entity Analytic Code Research and Clinical Center for Infertility, Shahid empty Sadoughi University of Medical Sciences Data Dictionary Full name of responsible person empty 3.