CompletedNot Applicable

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

Italy90 participantsStarted 2025-02-01

Plain-language 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).

Who can participate

Age range30 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Operative results

Timeframe: 8 months

Surgical results

Timeframe: 8 months

Hysteroscopic results

Timeframe: 8 months

Trial details

NCT IDNCT06768086

SponsorCentro di Ricerca Clinica Salentino

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Uterine Fibroids trials