GnRH Agonist Pretreatment in Hysteroscopic Myomectomy

NCT ID: NCT01873378

Last Updated: 2015-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Uterine Myoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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GnRH agonist pretreatment

triptorelin 3.75 mg, im, monthly, three times

Group Type EXPERIMENTAL

Triptorelin 3.75 mg

Intervention Type DRUG

No pharmacological treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Triptorelin 3.75 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera S. Maria della Misericordia

OTHER

Sponsor Role lead

Responsible Party

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Sandro Gerli

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sandro gerli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Perugia, Perugia, Italy

Locations

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Arbor Vitae Endoscopic Centre

Rome, Italy, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 29180306 (View on PubMed)

Other Identifiers

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GnRHa hysteroscopic myomectomy

Identifier Type: -

Identifier Source: org_study_id

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