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

NCT06768086 | Completed

• 1 other identifier: CER1024
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

uterine fibroid; uterine myoma; hysteroscopic myomectomy; D-Chiro-Inositol; Epigallocatechin Gallate; Vitamin D; Surgical complication

Outcome Measures

Primary Outcomes (3)

• Operative results

  to compare the operative results between the 2 study groups: duration of surgery in min

  8 months

• Surgical results

  to compare the operative results between the 2 study groups: the volume of fluid infused in ml

  8 months

• Hysteroscopic results

  to compare the operative results between the 2 study groups: the volume of fluid absorbed in ml

  8 months

Secondary Outcomes (1)

• Complete resection of fibroids

  8 months

Other Outcomes (2)

• Patients' complications

  8 months

• Patients' compliance

  8 months

Study Arms (2)

Treated patiens' Group as Group 1

Pre-treated patients by Eutris Plus for 3 months and the hysteroscopic myomectomy

Procedure: Hysteroscopic myomectomy

Untreated patiens' Group as Group 2

Control group of women (no treatments and without preoperative hormonal therapy) scheduled to undergo hysteroscopic myomectomy after 3 months.

Procedure: Hysteroscopic myomectomy

Interventions

Hysteroscopic myomectomy PROCEDURE

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.

Treated patiens' Group as Group 1; Untreated patiens' Group as Group 2

Eligibility Criteria

• Age: 30 Years - 45 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women of reproductive age, in good health, without pathologies compromising general anesthesia and willing to participate in the study, on a voluntary basis. The decision about whether to pretreat patients medically or not, was twice: 1. patient' preference design. 2. if the patients were undecided, at the discretion of the staff physician, as was the choice of therapy.

You may qualify if:

• Clinical diagnosis of FIGO type 0 to 2 fibroids, with a diameter of 20 - 35 mm. Must be able to swallow tablets.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro di Ricerca Clinica Salentino: lead

Study Sites (1)

Ospedale Veris delli Ponti

Scorrano, Lecce, 73020, Italy

Location

Related Publications (15)

• Tinelli 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 RESULT

• Tinelli 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 RESULT

• Vafaei 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 RESULT

• Ali 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 RESULT

• Lethaby 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 RESULT

• Wlodarczyk 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 RESULT

• Kamal 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.

  PMID: 34063635 RESULT

• Hazimeh D, Massoud G, Parish M, Singh B, Segars J, Islam MS. Green Tea and Benign Gynecologic Disorders: A New Trick for An Old Beverage? Nutrients. 2023 Mar 16;15(6):1439. doi: 10.3390/nu15061439.

  PMID: 36986169 RESULT

• Krzyzanowski J, Paszkowski T, Wozniak S. The Role of Nutrition in Pathogenesis of Uterine Fibroids. Nutrients. 2023 Dec 1;15(23):4984. doi: 10.3390/nu15234984.

  PMID: 38068842 RESULT

• Szydlowska I, Nawrocka-Rutkowska J, Brodowska A, Marciniak A, Starczewski A, Szczuko M. Dietary Natural Compounds and Vitamins as Potential Cofactors in Uterine Fibroids Growth and Development. Nutrients. 2022 Feb 9;14(4):734. doi: 10.3390/nu14040734.

  PMID: 35215384 RESULT

• Arjeh S, Darsareh F, Asl ZA, Azizi Kutenaei M. Effect of oral consumption of vitamin D on uterine fibroids: A randomized clinical trial. Complement Ther Clin Pract. 2020 May;39:101159. doi: 10.1016/j.ctcp.2020.101159. Epub 2020 Apr 2.

  PMID: 32379687 RESULT

• Combs A, Singh B, Nylander E, Islam MS, Nguyen HV, Parra E, Bello A, Segars J. A Systematic Review of Vitamin D and Fibroids: Pathophysiology, Prevention, and Treatment. Reprod Sci. 2023 Apr;30(4):1049-1064. doi: 10.1007/s43032-022-01011-z. Epub 2022 Aug 12.

  PMID: 35960442 RESULT

• Vergara D, Catherino WH, Trojano G, Tinelli A. Vitamin D: Mechanism of Action and Biological Effects in Uterine Fibroids. Nutrients. 2021 Feb 11;13(2):597. doi: 10.3390/nu13020597.

  PMID: 33670322 RESULT

• Porcaro G, Santamaria A, Giordano D, Angelozzi P. Vitamin D plus epigallocatechin gallate: a novel promising approach for uterine myomas. Eur Rev Med Pharmacol Sci. 2020 Mar;24(6):3344-3351. doi: 10.26355/eurrev_202003_20702.

  PMID: 32271452 RESULT

• Grandi G, Del Savio MC, Melotti C, Feliciello L, Facchinetti F. Vitamin D and green tea extracts for the treatment of uterine fibroids in late reproductive life: a pilot, prospective, daily-diary based study. Gynecol Endocrinol. 2022 Jan;38(1):63-67. doi: 10.1080/09513590.2021.1991909. Epub 2021 Oct 16.

  PMID: 34658291 RESULT

MeSH Terms

Conditions

Leiomyoma; Patient Compliance; Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrea Tinelli, MD

  Veris delli Ponti Hospital Scorrano, 73020 Lecce, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 10, 2025
• Study Start: February 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: November 25, 2025
• Last Updated: December 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)