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Search / Trial NCT06768086

Preoperative Administration of EGCG, Vitamin D and DCI Prior Hysteroscopic Myomectomy

Launched by CENTRO DI RICERCA CLINICA SALENTINO · Jan 9, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Uterine Fibroid Uterine Myoma Hysteroscopic Myomectomy D Chiro Inositol Epigallocatechin Gallate Vitamin D Surgical Complication

ClinConnect Summary

This clinical trial is studying the effects of a combination of three substances—Epigallocatechin gallate (EGCG), Vitamin D, and D-Chiro-Inositol (DCI)—on women who are preparing for a specific type of surgery called hysteroscopic myomectomy to remove uterine fibroids. The researchers want to find out if taking these substances for three months before surgery can help reduce the size of fibroids and improve symptoms compared to women who do not receive this treatment before their operation.

To participate in the trial, women must have a diagnosis of certain types of fibroids (specifically, types 0 to 2) that are between 20 and 35 millimeters in size, and they should be able to swallow tablets. However, those with other conditions, like polyps or more than two fibroids, will not be eligible. The study is not yet recruiting, but once it starts, participants can expect to be divided into two groups: one that receives the treatment and one that does not. Throughout the trial, the researchers will collect information to see how the treatment affects the surgery outcomes. This study could provide valuable insights into new ways to help women with uterine fibroids.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Clinical diagnosis of FIGO type 0 to 2 fibroids, with a diameter of 20 - 35 mm. Must be able to swallow tablets.
  • Exclusion Criteria:
  • Clinical diagnosis of polyps associated to FIGO type 0 to 2 fibroids. Non-hysteroscopic surgical procedures. The presence of more than 2 FIGO type 0 to 2 fibroids.

About Centro Di Ricerca Clinica Salentino

Centro di Ricerca Clinica Salentino is a leading clinical research organization dedicated to advancing medical science through innovative clinical trials. With a focus on patient-centered research, the center collaborates with healthcare professionals and industry partners to facilitate the development of new therapies and medical interventions. Committed to maintaining the highest ethical standards and regulatory compliance, the center emphasizes rigorous scientific methodology and comprehensive data analysis, ensuring the integrity and reliability of its findings. By fostering a collaborative environment, Centro di Ricerca Clinica Salentino aims to contribute significantly to the improvement of healthcare outcomes both locally and globally.

Locations

Scorrano, Lecce, Italy

Patients applied

0 patients applied

Trial Officials

Andrea Tinelli, MD

Principal Investigator

Veris delli Ponti Hospital Scorrano, 73020 Lecce, Italy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported