Clinical trial · Interventional
Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel
Incidence of Intrauterine Adhesions Following Myomectomies With the Use of an Intrauterine Anti-adhesion Gel
- 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)
This prospective randomized study aims to evaluate whether the application of an intrauterine anti-adhesion gel reduces the incidence of intrauterine adhesions (IUAs) following robotic-assisted laparoscopic myomectomy. Intrauterine adhesions may develop after endometrial trauma during surgery and can negatively affect menstrual function, fertility, and future pregnancy outcomes. Robotic myomectomy offers a minimally invasive approach, but postoperative adhesion formation remains a concern. Sixty-two women undergoing myomectomy will be randomized to receive either intrauterine anti-adhesion gel (intervention group) or no adhesion-prevention method (control group). Adhesions will be assessed by ultrasound and hysteroscopy during follow-up. Secondary outcomes include reproductive results over a 24-month period, such as implantation rate, clinical pregnancy, miscarriage, live birth, pregnancy complications, and neonatal outcomes. The study seeks to determine whether combining a minimally invasive surgical approach with an intrauterine gel provides additional protection against adhesion formation and improves fertility-related outcomes.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adhesion; Uterus, Internal | — | UNRESOLVED | — |
| Myoma;Uterus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Anti-adhesion gel group
- description
- Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure.
- interventionNames
- Device: Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure
- type
- NO_INTERVENTION
- label
- Standard of care group
- description
- Women will not receive any anti-adhesion methods
Primary outcomes (1)
- measure
- Efficacy of intrauterine gel in reducing the formation of intrauterine adhesions
- timeFrame
- Up to two months after surgery
- description
- The primary objective of the study is to evaluate the efficacy of intrauterine gel in reducing the formation of intrauterine adhesions following robotic-assisted laparoscopic myomectomy. Intrauterine adhesions will be assessed during follow-up ultrasound performed one month after surgery and by diagnostic hysteroscopy two months after surgery. Adhesions will be classified according to an internationally recognized scoring system. The severity, extent, and type of adhesions will be documented using the American Fertility Society (AFS) / American Society for Reproductive Medicine (ASRM) classification system, which categorizes IUAs as mild, moderate, or severe based on the extent of cavity involvement, type of adhesions, and menstrual pattern.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 45 years; * BMI 18-35; * One or more fibroids diagnosed via ultrasound; * First myomectomy or uterine surgery; * Incomplete reproductive plans and/or infertility; * Adequate immune, respiratory, liver, cardiac, bone marrow, and kidney function; * Compliance and psychological ability to follow study procedures; * Acceptance and signing of informed consent. Exclusion Criteria: * Age under 18 years; * Age over 46 years; * Pregnancy or breastfeeding; * History of intrauterine adhesions; * Diagnosis or suspicion of malignant gynecological pathologies and/or autoimmune diseases; * Completed reproductive plans; * Severe respiratory, bone marrow, liver, or kidney dysfunction preventing safe surgical access.
References
Publications (19)
- BACKGROUNDMercorio A, Della Corte L, Boccia D, Palumbo M, Reppuccia S, Buonfantino C, Cuomo L, Borgo M, Zitiello A, De Angelis MC, Lagana AS, Bifulco G, Giampaolino P. Myomectomy in infertile women: More harm than good? Front Surg. 2023 Apr 17;10:1151901. doi: 10.3389/fsurg.2023.1151901. eCollection 2023. PMID 37139194
- BACKGROUNDBortoletto P, Keefe KW, Unger E, Hariton E, Gargiulo AR. Incidence and risk factors of intrauterine adhesions after myomectomy. F S Rep. 2022 May 28;3(3):269-274. doi: 10.1016/j.xfre.2022.05.007. eCollection 2022 Sep. PMID 36212555
- BACKGROUNDAsgari Z, Hafizi L, Hosseini R, Javaheri A, Rastad H. Intrauterine synechiae after myomectomy; laparotomy versus laparoscopy: Non-randomized interventional trial. Iran J Reprod Med. 2015 Mar;13(3):161-8. PMID 26000007
- BACKGROUNDLagana AS, Garzon S, Dababou S, Uccella S, Medvediev M, Pokrovenko D, Babunashvili EL, Buyanova SN, Schukina NA, Shcherbatykh Kaschchuk MG, Kosmas I, Licchelli M, Panese G, Tinelli A. Prevalence of Intrauterine Adhesions after Myomectomy: A Prospective Multicenter Observational Study. Gynecol Obstet Invest. 2022;87(1):62-69. doi: 10.1159/000522583. Epub 2022 Feb 15. PMID 35168241
- BACKGROUNDCapmas P, Pourcelot AG, Fernandez H. Are synechiae a complication of laparotomic myomectomy? Reprod Biomed Online. 2018 Apr;36(4):450-454. doi: 10.1016/j.rbmo.2018.01.010. Epub 2018 Feb 2. PMID 29454580
- BACKGROUNDPellicano M, Guida M, Bramante S, Acunzo G, Di Spiezio Sardo A, Tommaselli GA, Nappi C. Reproductive outcome after autocrosslinked hyaluronic acid gel application in infertile patients who underwent laparoscopic myomectomy. Fertil Steril. 2005 Feb;83(2):498-500. doi: 10.1016/j.fertnstert.2004.09.019. PMID 15705404
- BACKGROUNDAcunzo G, Guida M, Pellicano M, Tommaselli GA, Di Spiezio Sardo A, Bifulco G, Cirillo D, Taylor A, Nappi C. Effectiveness of auto-cross-linked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic adhesiolysis: a prospective, randomized, controlled study. Hum Reprod. 2003 Sep;18(9):1918-21. doi: 10.1093/humrep/deg368.