Evaluation of the effects of endometrial scratching on angiogenic and anti-angiogenic growth factors expression in unexplained repeated implantation failure (RIF) patients

Determining the effect of endometrial scratching on the expression of angiogenic and anti-angiogenic growth factors

A randomized clinical trial with control group, double blind, and two arm parallel group design of 20 patients. Randomization is performed using a computer-generated random assignment schedule for each patient. Sealed and numbered envelopes are used to conceal the treatment allocation until randomization.

Using a pipelle, endometrial scratching is performed by a gynecologist only in the intervention group in the clinic. In this study, the participating patients (creating the same conditions) and the researcher (through sample coding) will be blinded.

Inclusion criteria: age 20-40 years, BMI less than 25 kg/m2, good response to previous ovulation stimulation, at least two embryos with good grade in the current cycle, normal uterus. Inclusion criteria: Women with submucosal myoma, congenital anomalies, intramural and subserosal myoma, endometrioma, and hydrosalpinx. Less than 2 available embryos, use of specific drugs. history of diabetes, thyroid disease, or any endocrine, genetic, infection, or autoimmune disorder. Severe male factor infertility, previous uterine or ovarian surgery, abnormal results of pre-implantation genetic testing (PGT)

Intervention: In the intervention group, endometrial sampling is obtained twice by Pipelle [one in the follicular phase and the last in the luteal phase of the same cycle preceding the embryo transfer cycle. Control group: In the control group endometrial sampling will be done only in the luteal phase of the cycle preceding the embryo transfer cycle.

Determination of angiogenic and anti-angiogenic growth factor gene expression in endometrial specimens in the intervention group compared with the control group

In the previous report, we had reported the entry of the last person in the study as the end of sampling, but according to the evaluation of the rate of clinical pregnancy (5 weeks after embryo transfer) and live birth (9 months of pregnancy) in people participating in the project, so The final completion time increases. In addition to the clinical pregnancy criteria, the embryo implantation rate was also investigated in the study as one of the secondary objectives. The time of scraping and sampling has not changed in terms of time, but it is better to specify it as a time frame. On the other hand, the inclusion and exclusion criteria of people in the study were applied more strictly. Also, in addition to angiogenic factors, anti-angiogenic factors were also evaluated in the study.

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.

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).

Clinical study report (published article)

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Dr. Mehrdad Bakhtiyari

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