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Completed

NCT Number: NCT01873378

GnRH Agonist Pretreatment in 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.

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Key information

Conditions

Uterine Myoma Connective Tissue Diseases Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arbor Vitae Endoscopic Centre

Rome, Italy, 00191

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triptorelin 3.75 mg

Drug

Primary outcomes

  1. 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 outcomes

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

    Time frame: Just finished the surgical procedure.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera S. Maria della Misericordia

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2013
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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