Clinical trial · Observational
Preoperative Administration of EGCG, Vitamin D and DCI Prior Hysteroscopic Myomectomy
3 Months Preoperative Administration of Eutris Plus Prior Hysteroscopic Myomectomy: a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hysteroscopic Myomectomy | — | UNRESOLVED | — |
| Patient Compliance | — | UNRESOLVED | — |
| Treatment Compliance | — | UNRESOLVED | — |
| Treatment Complication | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hysteroscopic myomectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Treated patiens' Group as Group 1
- description
- Pre-treated patients by Eutris Plus for 3 months and the hysteroscopic myomectomy
- interventionNames
- Procedure: Hysteroscopic myomectomy
- label
- Untreated patiens' Group as Group 2
- description
- Control group of women (no treatments and without preoperative hormonal therapy) scheduled to undergo hysteroscopic myomectomy after 3 months.
- interventionNames
- Procedure: Hysteroscopic myomectomy
Primary outcomes (3)
- measure
- Operative results
- timeFrame
- 8 months
- description
- to compare the operative results between the 2 study groups: duration of surgery in min
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (15)
- RESULTTinelli A, Gustapane S, D'Oria O, Licchelli M, Panese G. Nutraceuticals in fibroid management after ulipristal acetate administration: An observational study on patients' compliance. Int J Gynaecol Obstet. 2022 Jan;156(1):133-138. doi: 10.1002/ijgo.13692. Epub 2021 May 5. PMID 33797759
- RESULTTinelli A, Panese G, Licchelli M, Morciano A, Pecorella G, Gambioli R. The impact of epigallocatechin gallate, vitamin D, and D-chiro-inositol on early surgical outcomes of laparoscopic myomectomy: a pilot study. Arch Gynecol Obstet. 2024 Mar;309(3):1021-1026. doi: 10.1007/s00404-023-07324-x. Epub 2024 Jan 6. PMID 38183422
- RESULTVafaei S, Ciebiera M, Omran MM, Ghasroldasht MM, Yang Q, Leake T, Wolfe R, Ali M, Al-Hendy A. Evidence-Based Approach for Secondary Prevention of Uterine Fibroids (The ESCAPE Approach). Int J Mol Sci. 2023 Nov 4;24(21):15972. doi: 10.3390/ijms242115972. PMID 37958957
- RESULTAli M, Ciebiera M, Wlodarczyk M, Alkhrait S, Maajid E, Yang Q, Hsia SM, Al-Hendy A. Current and Emerging Treatment Options for Uterine Fibroids. Drugs. 2023 Dec;83(18):1649-1675. doi: 10.1007/s40265-023-01958-6. Epub 2023 Nov 3. PMID 37922098
- RESULTLethaby A, Puscasiu L, Vollenhoven B. Preoperative medical therapy before surgery for uterine fibroids. Cochrane Database Syst Rev. 2017 Nov 15;11(11):CD000547. doi: 10.1002/14651858.CD000547.pub2. PMID 29139105
- RESULTWlodarczyk M, Ciebiera M, Nowicka G, Lozinski T, Ali M, Al-Hendy A. Epigallocatechin Gallate for the Treatment of Benign and Malignant Gynecological Diseases-Focus on Epigenetic Mechanisms. Nutrients. 2024 Feb 17;16(4):559. doi: 10.3390/nu16040559. PMID 38398883
- RESULTKamal DAM, Salamt N, Zaid SSM, Mokhtar MH. Beneficial Effects of Green Tea Catechins on Female Reproductive Disorders: A Review. Molecules. 2021 May 3;26(9):2675. doi: 10.3390/molecules26092675.