Previously submitted to: JMIR Research Protocols (no longer under consideration since Jan 27, 2023)
Date Submitted: May 5, 2022
Open Peer Review Period: Jan 9, 2023 - Mar 9, 2023
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Evaluation of Serum Vegf - A and Interleukin 6 as Predictors of Angiogenesis During Peri-Implantation Period Assessed by Transvaginal Doppler Ultrasonography Amongst Women of Prior Reproductive Failure.
ABSTRACT
Background:
Infertility is a wide spectrum of disorder affecting many couples and is defined as the inability of a couple to achieve pregnancy. A series of investigations are required to know the reason behind infertility, yet a small percentage (08-37%) of couples exist, in which no obvious cause is delineated. Infertility causes enormous emotional, physiological, psychological, sexual, social and financial burden on family. Different hormones, growth factors and interleukins are responsible for successful ovulation, implantation and further growth of embryo. Endometrial receptivity is an important predictor of the outcome of implantation and further growth of embryo.
Objective:
1. To assess IL6 and VEGF-A serum level in relation to angiogenesis by Transvaginal ultrasonography in Reproductive failure group. 2. To assess IL6 and VEGF-A serum levels correlation with angiogenesis by Transvaginal ultrasonography in fertile control group. 3. Comparison of IL6, VEGF-A and angiogenesis in between women of fertile group and women of reproductive failure group. 4. To assess the reproductive outcome of the women of study group in the same cycle. 5. To assess the potential of combined values of VEGF-A, IL6 and Transvaginal doppler ultrasonography as a marker for endometrial receptivity. 6. To compare the new scoring system generated out of 3 parameters (Serum VEGF-A, IL6 and TVS Doppler – PREDICGIO) with ERA on the basis of existing evidences in literature.
Methods:
The study would be conducted in a tertiary care centre over a period of two years from July 2022 till July 2024 on non-pregnant unexplained infertile women (63) who will undergo In Vitro Fertilisation and Embryo Transfer (IVF-ET) in the following cycle and the result will be compared with the fertile women (21) with same demographic features. The levels of serum Vascular Endothelial Growth factor – A, Interleukin- 6 will be measured on day 21 of the menstrual cycle in both the group, simultaneously, transvaginal ultrasonography and doppler findings will be measured in both groups to see for endometrial receptivity. The values will be compared for any significance.
Results:
The values of Serum VEGF-a, IL6 and Doppler findings will be compared between fertile and infertile group to see for significance difference. The main reason behind doing research on this topic is to find a more cost effective, non-invasive and less time-consuming technique to find Endometrial Receptivity as compared to invasive Endometrial Receptivity Analysis (ERA) Technique. Also, a new scoring system will be developed considering these 3 parameters of endometrial receptivity (PREDICGIO scoring system) for better analysis of endometrial receptivity and to determine the method to be used in patients of infertility for getting pregnancy without much financial burden.
Conclusions:
The evidences of relationship between the combined evaluation of VEGF-A and IL 6 in angiogenesis during the peri implantation window in reproductive failure patients and their outcome observed by transvaginal doppler ultrasonography has not been done. This area of infertility is still in the dark side with little knowledge about the effects of the values of the growth factors and cytokines on the angiogenesis factor in reproductive failure. As most of the studies didn’t correlate inflammatory markers with angiogenesis. Any many of them have not associated reproductive outcome of study group. The actual role of these markers in angiogenesis will be studied and simultaneous assessment of these markers on endometrium will be seen by TVS doppler. The data collected from these patients will be used to prepare a new scoring system for angiogenesis considering all 3 parameters (VEGF-A, IL6 and TVS Doppler) according to which prediction of angiogenesis will be done and outcome will be assessed in the form of pregnancy in same cycle. Scoring system can be used to put patients on immunomodulators in later cycles. A more cost effective, non invasive, less time consuming method to detect angiogenesis and outcome will be studied, which can be considered in place of costly techniques like Endometrial Receptivity Analysis for patients of reproductive failure. Clinical Trial: Datta Meghe Institute of Medical Sciences, Sawangi, Wardha, Institutional Ethical Committee clearance obtained on 29/9/2021. Re- regd no: ECR/440/Inst/MH/2013/RR-2019 Ref. no: DMIMS(du)/IEC/2021/548
Citation
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