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IRCT20080831001141N28 IRCT 2020-11-25 ROYAN Institute Molecular evaluation of endometrium after endometrial injury RIF-Injury Molecular evaluation of endometrium obtained from women with repeated implantation failure (RIF) after endometrial injury in compare to women without endometrial injury 2014-06-30 anticipated 20 Complete https://irct.ir/trial/52496 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 8-9 or 11-13. The biopsy specimen is prepared in the luteal phase of the same cycle during days 19-21 or 20-23 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 conditions will be the same between the two groups, so patients in the control group also referred to the center on the day of scratching (on days 8-9 or 11-13) and due to the blindness of the study, all sampling steps except scratching The endometrium will be performed for the control group as well as the intervention group. The endometrial biopsy specimen of both groups is transferred to the Laboratory, which also does not know information about whether the tissue sample received is for the intervention or control group and examines it only based on the received code (researcher blindness). 2 repeated implantation failure (RIF). Intervention 1: Intervention group: In the intervention group, endometrial sampling is obtained twice by Pipelle [one in the follicular phase (during 8-9 or 11- 13 day in the beginning of buserelin cycle) and the last in the luteal phase (during 19-21 or 20-23 day) preceding the embryo transfer cycle.The endometrial injury which 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. Mahnaz Ashrafi How to obtain: Request via e-mail Comments:
public مهناز اشرفی
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2727 dr.mahnaz.ashrafi@gmail.com ROYAN Institute scientific Mahnaz Ashrafi
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2727 dr.mahnaz.ashrafi@gmail.com Royan Institute Iran (Islamic Republic of) Infertile women with repeated implantation failure (RIF) refers to cases in which women have had three failed in vitro fertilization (IVF) attempts with good quality embryos. 18 years 40 years Female Women with Sub mucosal myoma Women with Intramural and subserosal myomas larger than 5 cm Women with Endometrioma larger than or equal to 3 cm Women with Hydrosalpinx If the number of available embryos is less than 2 in the current cycle Women with endometrial tuberculosis and those undergoing tuberculosis treatment. Patients with any specific medication Patients with a history of thyroid disease, diabetes and other hormonal disorders and diseases Failure to return the patient to prepare an endometrial sample Inability to obtain tissue samples from patients due to severe pain 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 8-9 or 11- 13 day in the beginning of buserelin cycle) and the last in the luteal phase (during 19-21 or 20-23 day) preceding the embryo transfer cycle.The endometrial injury which 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 19-21 or 20-23. Method of measurement: Using PCR Array method and based on the copy number. Clinical pregnancy rate. Timepoint: Only once; 6 weeks after embryo transfer. Method of measurement: Vaginal ultrasound. NCT02480127 مرکز ثبت کارآزمائي هاي باليني ايالات متحده آمريکا (www.clinicaltrial.gov) ROYAN Institute Approved 2014-08-12 Ethics Committee of Royan Institute Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway. Tehran Tehran Iran (Islamic Republic of)