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IRCT2012091310328N3 IRCT 2013-01-12 Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente The effect of intrauterine human chorionic gonadotropin injection on pregnancy outcomes in infertile patients The effect of intrauterine human chorionic gonadotropin injection before embryo transfer on the implantation and pregnancy rate in infertile patients: A randomized clinical trial 2012-04-05 anticipated 159 Complete https://irct.ir/trial/10839 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Women who met the inclusion criteria were numbered from 1 to 159 in order of referral. After being explained about the study method and obtaining informed consent two columns of 53 random numbers from 1-159 were produced using statistical soft version Minitab 14 software (Minitab. LLC, 2014. Minitab, Available at: http://www.minitab.com); numbers that were not in these columns were considered as third group. Each lists was randomly assigned to one of the intervention groups A, B and C (control). The simple randomization method was used. Envelopes and codes were assigned for all participants. Group one was marked with A, group two with B and group three with C. A code has been assigned to each envelope and this code was recorded for each participant. 3 Infertility. Intervention 1: In control group (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed and 48-72 hours after between 2-3 embryo through of Cook catheter embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used . Intervention 2: In group 1 intervention (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(500 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS , 40 microliter of tissue culture medium containing 500 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used . Intervention 3: In group 2 intervention (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(1000 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS, 40 microliter of tissue culture medium containing 1000 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used . 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: Researchers working in academic and scientific institutes, Journal editors and Reviewers 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. 983538247085 How to obtain: Immediately after the Submission of an official application via the agent that is legally in charge (About a month) by sending an email to janati@dums.ac.ir. Comments:
public Dr.Sima Janati
Research and Clinical Center for Infertility, Bouali Ave, Safayeh,Yazd
Yazd Iran (Islamic Republic of) ۸۹۱۶۸۷۷۳۹۱ +98 35 1824 7085 janati@dums.ac.ir Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd scientific Dr.Razieh Dehghani Firouzabadi
Research and Clinical Center for Infertility, Bouali Ave, Safayeh، Yazd
Yazd Iran (Islamic Republic of) ۸۹۱۶۸۷۷۳۹۱ +98 35 1824 7085 dr-firouzabadi@ssu.ac.ir Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd Iran (Islamic Republic of) female age in the range of 20-40 years male factor infertility unexplained infertility basal FSH less than 12. 20 years 40 years Female azoospermia, presence of uterine myoma endometriosis hydrosalpinges previous IVF/ICSI trials (successful or unsuccessful) history of endocrine diseases such as diabetes and thyroid dysfunction previous history of hysterocopic operation due to submoucosal myoma, and intrauterine synechia. N98.3 Complications of attempted introduction of embryo in embryo transfe Treatment - Drugs Treatment - Drugs Treatment - Drugs In control group (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed and 48-72 hours after between 2-3 embryo through of Cook catheter embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used . In group 1 intervention (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(500 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS , 40 microliter of tissue culture medium containing 500 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used . In group 2 intervention (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(1000 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS, 40 microliter of tissue culture medium containing 1000 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used . Implantation rate. Timepoint: Identified through vaginal or abdominal ultrasound 4-5 wks after the embryo transfer. Method of measurement: Observation of number of gestational sacs by transvaginal ultrasonography per 100 embryo transfer. Chemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: BHCG test. Clinical pregnancy. Timepoint: 4 -5 weeks after embryo transfer. Method of measurement: observation of fetal heart activity by trans vaginal or abdominal ultrasound. Abortion. Timepoint: Before the 20th week of pregnancy. Method of measurement: Abortion product observation (placenta and fetus residual). Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente Approved 2012-03-15 Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd Research and Clinical Center for Infertility, Bouali Ave, Safayeh, Yazd Yazd Yazd Iran (Islamic Republic of)