GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

Uterine Myoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873378
• Other study ID #: GnRHa hysteroscopic myomectomy
• Status: Completed
• Phase: N/A
• First received: June 1, 2013
• Last updated: August 10, 2015
• Start date: January 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Azienda Ospedaliera S. Maria della Misericordia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Myoma

Intervention

Drug:
• Triptorelin 3.75 mg

Locations

Country	Name	City	State
Italy	Arbor Vitae Endoscopic Centre	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera S. Maria della Misericordia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure.		Just finished the surgical procedure.	Yes
Secondary	Minutes (surgical procedure time), milliliters (fluid absorption during the procedure).		Just finished the surgical procedure.	Yes