GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

August 10, 2015 updated by: Sandro Gerli, Azienda Ospedaliera S. Maria della Misericordia

Surgical Effects of GnRH Agonist Pretreatment on Cold Loop Hysteroscopic Myomectomy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00191
        • Arbor Vitae Endoscopic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GnRH agonist pretreatment
triptorelin 3.75 mg, im, monthly, three times
Drug: Triptorelin 3.75 mg
No Intervention: No pharmacological treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Just finished the surgical procedure.

Secondary Outcome Measures

Outcome Measure
Time Frame
Minutes (surgical procedure time), milliliters (fluid absorption during the procedure).
Time Frame: Just finished the surgical procedure.
Just finished the surgical procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera S. Maria della Misericordia

Investigators

  • Principal Investigator: sandro gerli, MD, University of Perugia, Perugia, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 1, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GnRHa hysteroscopic myomectomy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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