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IRCT20110731007165N4 IRCT 2018-08-31 Tehran University of Medical Sciences Comparison of local endometrial injury efficacy in follicular versus luteal phases on the success rate of frozen embryo transfer cycle Comparison of the effect local endometrial injury on implantation and pregnancy rate in follicular versus luteal phases of the menstrual cycle in patients undergoing frozen embryo transfer with a history of at least one IVF failure 2017-09-23 anticipated 136 Complete https://irct.ir/trial/7605 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Our considered sample size is 136 (with 68 people in each group). Block randomization method will be designed by using online randomization list provided by https://www.sealedenvelope.com. N/A Female infertility. Intervention 1: in group 1: Making endometrial injury by pipelle instrument in the follicular phase ( at days 4–6 and before FET).The LEI process will be performed with scratching endometrium by using an endometrial pipelle instrument. After 14 days, If the Triple line endometrium pattern is seen or endometrial thickness is above 7 mm, progesterone will be started as a Cyclogest suppository. After at least 3 to 4 days, two or three frozen embryos (two to three days old) will be transferred. `. Intervention 2: in group 2: Making endometrial injury by pipelle instrument in the luteal phase ( at days 21-23 and before FET). The LEI process will be performed with scratching endometrium by using an endometrial pipelle instrument. After 14 days, If the Triple line endometrium pattern is seen or endometrial thickness is above 7 mm, progesterone will be started as a Cyclogest suppository. After at least 3 to 4 days, two or three frozen embryos (two to three days old) will be transferred. `. 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 The research team has not yet made a decision on how to publish the results or the statistical analysis map.
public Dr.Zahra Parsaeian
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 zparsaiyan6@gmail.com Arash Women 's Hospital scientific Dr.Ladan Kashani
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 Kashani_ladan@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Aged under 40 years old Hysterosalpingography (HSG) or hysteroscopy showed a normal uterine cavity Body Mass Index < 30 Have a history of one or more IVF failures Women who were not using Oral Contraceptives (OCP) or GnRH in previous ART cycle Have indication for LEI (Local Endometrial injury) Patients who had given their written, informed consent for participation no limit 40 years Female Intrauterine abnormalities shown in sonography or imaging such as myoma, Ascherman syndrome, etc ...), endometrial hyperplasia and cancer Active vaginal and cervical infections Systemic disease (systemic lupus eritematoso, Diabetes, Hypertension, etc ... ) N97 inability to achieve a pregnancy sterility, female NOS Treatment - Other Treatment - Other in group 1: Making endometrial injury by pipelle instrument in the follicular phase ( at days 4–6 and before FET).The LEI process will be performed with scratching endometrium by using an endometrial pipelle instrument. After 14 days, If the Triple line endometrium pattern is seen or endometrial thickness is above 7 mm, progesterone will be started as a Cyclogest suppository. After at least 3 to 4 days, two or three frozen embryos (two to three days old) will be transferred. ` in group 2: Making endometrial injury by pipelle instrument in the luteal phase ( at days 21-23 and before FET). The LEI process will be performed with scratching endometrium by using an endometrial pipelle instrument. After 14 days, If the Triple line endometrium pattern is seen or endometrial thickness is above 7 mm, progesterone will be started as a Cyclogest suppository. After at least 3 to 4 days, two or three frozen embryos (two to three days old) will be transferred. ` Chemical Pregnancy Rate. Timepoint: 2 weeks after FET. Method of measurement: Pregnancy test ( BHCG ). Implantation Rate. Timepoint: 5 weeks after positive BHCG Test. Method of measurement: Trans Vaginal Sono. Ongoinig Pregnancy Rate. Timepoint: upto 12 weeks of gestation. Method of measurement: Diagnosis of gynecologist. Tehran University of Medical Sciences Approved 2017-07-22 Ethics committee of Tehran University of Medical Sciences Qods St, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)