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

NCT06768086 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2025-12-04

No results posted yet for this study

Summary

The administration of Epigallocatechin gallate (EGCG), Vitamin D and D-Chiro-Inositol (DCI) are effective in reducing the volume of fibroids and improving the symptoms of uterine fibroids.

Since this benefit has been seen in laparoscopic myomectomy, a study was designed to see if there are positive effects in women undergoing hysteroscopic myomectomy.

For this reason, patients were enrolled to undergo hysteroscopic myomectomy, then divided into two groups: patients to be treated preoperatively with a product based on Epigallocatechin gallate (EGCG), Vitamin D and D-Chiro-Inositol (DCI) for 3 months before myomectomy and patients not to be treated before surgery. All clinical and surgical parameters were then collected and analyzed to verify the differences between the two groups (treated women VS untreated women).

Conditions

  • Uterine Fibroids
  • Hysteroscopic Myomectomy
  • Treatment Compliance
  • Patient Compliance
  • Treatment Complication

Interventions

PROCEDURE

Hysteroscopic myomectomy

The hysteroscopic myomectomies were conducted during the follicular phase of the menstrual cycle. Throughout the surgical procedure, the intrauterine pressure was meticulously maintained at less than 80 mm Hg. Data on the duration of the surgical intervention, the volume of fluid administered, and the volume of fluid absorbed were collected. Complete resection was characterized as the total excision of the myoma. The determination of the completeness of myomectomy was made by the experienced surgeon during the surgical process. In instances where the resection was deemed incomplete, the decision to pursue a secondary surgical intervention was predicated on ultrasonographic evaluations, the symptomatic presentation of the patients, and, in certain circumstances, the findings from diagnostic hysteroscopy. Cases in which access to the uterine cavity was unfeasible were classified as "failed procedures" and were subsequently excluded from the study.

Sponsors & Collaborators

  • Centro di Ricerca Clinica Salentino

    lead NETWORK

Principal Investigators

  • Andrea Tinelli, MD · Veris delli Ponti Hospital Scorrano, 73020 Lecce, Italy

Eligibility

Min Age
30 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-09-30
Completion
2025-11-25

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06768086 on ClinicalTrials.gov