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IRCT20210316050723N1 IRCT 2021-07-12 Iran University of Medical Sciences Evaluation of the effects of endometrial scratching on angiogenic and anti-angiogenic growth factors Evaluation of the effects of endometrial scratching on angiogenic and anti-angiogenic growth factors expression in unexplained repeated implantation failure (uRIF) patients 2021-06-20 anticipated 20 Complete https://irct.ir/trial/56957 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Consecutive sampling until the required sample size is reached. Women by Balanced Block Randomization method are randomly divided into 2 equal groups of 10 people (intervention group and control group). Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 4. Envelopes are prepared for 20 people and inside each envelope is written the group in which the patient should be placed. The envelopes are prepared in a way that the writing inside is not clear. A nurse before the patient enters the operating room, removes the envelope and sends the patients in one of the two groups, Blinding description: In this study, a doctor scratches the endometrium in the intervention group on days 8-11. The biopsy specimen is prepared in the luteal phase of the same cycle during days 19-23 by the same doctor or other. Therefore, in this study, it is not possible to blind the doctor. In order to blind the patients participating in this study, all the conditions will be the same between the two groups, so the patients of the control group also referred to the center on the day of the scratching (8-11) and due to the blinding of the study, all the sampling steps were done except endometrial scratching will be done for the control group as well as the intervention group. Then, biopsy samples are prepared from both groups in the luteal phase on days 19-23. The endometrial biopsy sample of both groups is sent to the laboratory, which does not know whether the tissue sample received is for the intervention group or the control group, and only checks it based on the received code (blinding of the researcher). 2 Unexplained repeated implantation failure (uRIF). Intervention 1: Intervention group: In the intervention group, endometrial sampling is obtained twice by Pipelle [one in the follicular phase (during 8-11 days and the last in the luteal phase (during 19-23 days) preceding the embryo transfer cycle. The endometrial scratching is induced with pipelle. Intervention 2: Control group: In the control group endometrial sampling will be done only in the luteal phase of the cycle preceding the embryo transfer cycle. Yes - There is a plan to make this available What will be shared: Clinical study report (published article) When: After the publication of the article To whom: Available to the public Conditions: Scientific use by citing the source Where to obtain: Dr. Mehrdad Bakhtiyari How to obtain: Request via e-mail Comments:
public Mehrdad Bakhtiyari
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4567 mehr_bakhtiyari@yahoo.com Iran University of Medical Sciences scientific Mehrdad Bakhtiyari
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4567 Mehr_bakhtiyari@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Infertile women with unexplained repeated implantation failure (unknown definite causes of RIF) failed to conceive after three or more embryo transfer cycles using high-quality transferred embryos (at least one blastocyst ET cycle) Age of 20 to 40 years Body mass index (BMI) less than 25 kg/m2 Good response to stimulation of previous ovulation Having at least two embryos with good grade normal uterus results of hysterosalpingography (HSG) or hysteroscopy Participant consent was required to join in the study and to complete the consent form 20 years 40 years Female The thickness of the endometrium on the day of Human chorionic gonadotropin hormone injection is less than 7 mm Women with congenital anomalies, intramural and subserosal myomas( larger than 5 cm) Submucosal myoma Women with endometrioma larger than or equal to 3 cm With adhesions With hydrosalpinx Have previous uterine or ovarian surgery Severe male factor infertility (sperm extraction from the testis, sperm freezing, sperm DNA fragmentation index equal to or above 16%) Patients with any specific medication If the number of available embryos is less than 2 in the current cycle Women with endometrial tuberculosis and those undergoing tuberculosis treatment Have a history of diabetes, thyroid disease, any endocrine, genetic, infection or autoimmune disorder Abnormal Pre-implantation Genetic Test (PGT) Results Any specific medication Failure to return the patient to prepare an endometrial sample Women with severe pain during obtaining of tissue samples or the possibility of infection N97.9 Female infertility, unspecified Treatment - Other Treatment - Other Intervention group: In the intervention group, endometrial sampling is obtained twice by Pipelle [one in the follicular phase (during 8-11 days and the last in the luteal phase (during 19-23 days) preceding the embryo transfer cycle. The endometrial scratching is induced with pipelle. Control group: In the control group endometrial sampling will be done only in the luteal phase of the cycle preceding the embryo transfer cycle. Evaluation of gene expression. Timepoint: In the endometrial sample obtained in the luteal phase during days 19-23. Method of measurement: Using PCR Array method and based on the copy number. Clinical pregnancy. Timepoint: 5 weeks after embryo transfer. Method of measurement: Vaginal ultrasonography (observing the gestational sac and fetal heart rate). Implantation. Timepoint: 5 weeks after embryo transfer. Method of measurement: The number of observed sacs divided by the number of transferred embryos. Total dose of gonadotropin (IU). Timepoint: From ovarian stimulation to human chorionic gonadotropin (hCG) injection. Method of measurement: The number of international units (IU) received during the ovarian stimulation cycle. Duration of ovarian stimulation (day). Timepoint: From the start of gonadotropin administration to human chorionic gonadotropin (hCG) injection. Method of measurement: According to the patient's monitoring ultrasound chart (number of days receiving the medicine). Number of retrieved oocytes. Timepoint: On the day of oocyte pick-up. Method of measurement: The number of retrieved oocytes reported in the embryology chart. Metaphase II oocytes. Timepoint: On the day of oocyte pick-up. Method of measurement: Based on the presence of the polar body reported by the embryologist. Number of embryos. Timepoint: Three or five days after oocyte pick-up. Method of measurement: The number of cleavage embryos reported by the embryologist. Embryo transfer cancelation. Timepoint: Three or five days after oocyte pick-up. Method of measurement: Participants with no embryo transfer. Chemical pregnancy rate/Embryo transfer. Timepoint: 2 weeks after embryo transfer. Method of measurement: Beta human chorionic gonadotropin (beta hCG) titer in blood serum by ELISA method. Blighted ovum/Embryo transfer. Timepoint: 5 weeks after embryo transfer. Method of measurement: Absence of fetus in gestational sac according to ultrasound report. Ectopic pregnancy/Embryo transfer. Timepoint: 5 weeks after embryo transfer. Method of measurement: According to the ultrasound report, there is a gestational sac outside the uterus with a positive Beta hCG titer. Miscarriage rate/Embryo transfer. Timepoint: Pregnancy loss before 20 weeks. Method of measurement: Excretion of pregnancy remnants with vaginal bleeding (absence of heartbeat according to ultrasound report). Multiple Pregnancy (Twin). Timepoint: 5 weeks after embryo transfer. Method of measurement: Ultrasound report based on the number of gestational sacs with embryo. Live birth rate/Embryo transfer. Timepoint: Time of delivery. Method of measurement: Birth of a live baby. Fertilization rate. Timepoint: The day after the sperm injection. Method of measurement: number of oocytes with two pronuclei (2PN) divided by the number of injected oocytes. Iran University of Medical Sciences Approved 2021-06-12 Research Ethics Committees of school of medicine Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)