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GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

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ClinicalTrials.gov Identifier: NCT01873378
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Sandro Gerli, Azienda Ospedaliera S. Maria della Misericordia

Tracking Information
First Submitted Date  ICMJE June 1, 2013
First Posted Date  ICMJE June 10, 2013
Last Update Posted Date August 11, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
To assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure. [ Time Frame: Just finished the surgical procedure. ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
Minutes (surgical procedure time), milliliters (fluid absorption during the procedure), 0-3 scale (difficulty of the procedure), 0-3 scale (quality of image) [ Time Frame: 5 minutes after the end of the surgical procedure. ]
Change History Complete list of historical versions of study NCT01873378 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
Minutes (surgical procedure time), milliliters (fluid absorption during the procedure). [ Time Frame: Just finished the surgical procedure. ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GnRH Agonist Pretreatment in Hysteroscopic Myomectomy
Official Title  ICMJE Surgical Effects of GnRH Agonist Pretreatment on Cold Loop Hysteroscopic Myomectomy.
Brief Summary The primary outcome of this study is to assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic therapy in terms of distension liquid absorption and duration of the procedures.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Uterine Myoma
Intervention  ICMJE Drug: Triptorelin 3.75 mg
Study Arms  ICMJE
  • Experimental: GnRH agonist pretreatment
    triptorelin 3.75 mg, im, monthly, three times
    Intervention: Drug: Triptorelin 3.75 mg
  • No Intervention: No pharmacological treatment
Publications * Favilli A, Mazzon I, Grasso M, Horvath S, Bini V, Di Renzo GC, Gerli S. Intraoperative Effect of Preoperative Gonadotropin-Releasing Hormone Analogue Administration in Women Undergoing Cold Loop Hysteroscopic Myomectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2018 May - Jun;25(4):706-714. doi: 10.1016/j.jmig.2017.11.011. Epub 2017 Nov 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2015)
84
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2013)
60
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • submucous myoma diagnosed by vaginal ultrasonography and confirmed by diagnostic hysteroscopy
  • premenopausal status

Exclusion Criteria:

  • present or past history of cancer
  • pregnancy
  • presence of associated multiple polyps
  • presence of > 2 myomas
  • associated nonhysteroscopic surgical procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01873378
Other Study ID Numbers  ICMJE GnRHa hysteroscopic myomectomy
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sandro Gerli, Azienda Ospedaliera S. Maria della Misericordia
Study Sponsor  ICMJE Azienda Ospedaliera S. Maria della Misericordia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: sandro gerli, MD University of Perugia, Perugia, Italy
PRS Account Azienda Ospedaliera S. Maria della Misericordia
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP