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GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

Primary Purpose

Uterine Myoma

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Triptorelin 3.75 mg
Sponsored by
Azienda Ospedaliera S. Maria della Misericordia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Myoma focused on measuring Uterine myoma, GnRHa, Hysteroscopy, Cold loop

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arbor Vitae Endoscopic Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GnRH agonist pretreatment

No pharmacological treatment

Arm Description

triptorelin 3.75 mg, im, monthly, three times

Outcomes

Primary Outcome Measures

To assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure.

Secondary Outcome Measures

Minutes (surgical procedure time), milliliters (fluid absorption during the procedure).

Full Information

First Posted
June 1, 2013
Last Updated
August 10, 2015
Sponsor
Azienda Ospedaliera S. Maria della Misericordia
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1. Study Identification

Unique Protocol Identification Number
NCT01873378
Brief Title
GnRH Agonist Pretreatment in Hysteroscopic Myomectomy
Official Title
Surgical Effects of GnRH Agonist Pretreatment on Cold Loop Hysteroscopic Myomectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera S. Maria della Misericordia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Myoma
Keywords
Uterine myoma, GnRHa, Hysteroscopy, Cold loop

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GnRH agonist pretreatment
Arm Type
Experimental
Arm Description
triptorelin 3.75 mg, im, monthly, three times
Arm Title
No pharmacological treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Triptorelin 3.75 mg
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Minutes (surgical procedure time), milliliters (fluid absorption during the procedure).
Time Frame
Just finished the surgical procedure.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sandro gerli, MD
Organizational Affiliation
University of Perugia, Perugia, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arbor Vitae Endoscopic Centre
City
Rome
ZIP/Postal Code
00191
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
29180306
Citation
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.
Results Reference
derived

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GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

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