Protocol for Evaluating The Effect of Pelvic Physiotherapy on Uterine Blood Flow: A Single-Center, Two-Arm, Parallel, Randomized, Clinical Trial.

Abstract

Objective: Repeated implantation failure (RIF) is a major challenge in in vitro fertilization (IVF). Insufficient uterine blood flow and reduced endometrial thickness are important factors contributing to implantation failure. Pelvic physiotherapy, including electrotherapy, manual therapy, and exercise therapy, has shown potential to enhance endometrial thickness and improve local blood flow through pelvic floor exercises. Transfer of Energy Capacitive and Resistive (TECAR) therapy, a novel physiotherapy modality, promotes vasodilation, tissue oxygenation, and blood circulation. This study presents a clinical trial protocol designed to evaluate the effect of pelvic physiotherapy, comprising electrotherapy, exercise therapy, and TECAR therapy, on uterine blood supply in infertile women with RIF.

Materials and methods: Eligibility criteria include women with a history of at least two RIF events and inadequate uterine blood flow (pulsatility index (PI)> 1.95). The primary aim of this protocol is to evaluate uterine blood flow, endometrial thickness, and endometrial pattern, while secondary outcomes will include sexual function, depression, quality of life, pregnancy and implantation rates, fetal growth up to 12 weeks of gestation, ectopic pregnancy, and miscarriage. Following approval from the relevant ethics committee, this protocol will initially be implemented in a pilot phase involving 22 participants at Al-Zahra Hospital, Tabriz University of Medical Sciences.

Results: As of the protocol submission date, the pilot phase is planned but not yet completed. No participant data have been analyzed. Therefore, no results on uterine blood flow, endometrial thickness, implantation rates, or secondary outcomes are available at this stage. Upon completion of the pilot phase and subsequent full-scale trial, the findings will be reported separately.

Conclusion: The findings of the forthcoming trial are expected to contribute to establishing evidence-based physiotherapy approaches for improving uterine perfusion and implantation outcomes in infertile women with RIF (registration number: IRCT20230206057338N1).