GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

• Sponsor: Azienda Ospedaliera S. Maria della Misericordia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01873378
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Duration (Months): 30.9
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Myoma	Drug: Triptorelin 3.75 mg	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Surgical Effects of GnRH Agonist Pretreatment on Cold Loop Hysteroscopic Myomectomy.
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.]

Secondary Outcome Measures

1. Minutes (surgical procedure time), milliliters (fluid absorption during the procedure). [Just finished the surgical procedure.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arbor Vitae Endoscopic Centre	Rome		Italy	00191

Sponsors and Collaborators

• Azienda Ospedaliera S. Maria della Misericordia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sandro Gerli, Assistant Professor, Azienda Ospedaliera S. Maria della Misericordia
• ClinicalTrials.gov Identifier: NCT01873378
• Other Study ID Numbers: GnRHa hysteroscopic myomectomy
• First Posted: Jun 10, 2013
• Last Update Posted: Aug 11, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Sandro Gerli, Assistant Professor, Azienda Ospedaliera S. Maria della Misericordia: Uterine myoma; GnRHa; Hysteroscopy; Cold loop
• Additional relevant MeSH terms: Leiomyoma; Myofibroma; Triptorelin Pamoate

Study Results

No Results Posted as of Aug 11, 2015