Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients

NCT ID: NCT04270994

Last Updated: 2020-02-17

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

PHASE2/PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-11-30

Brief Summary

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Endometrial polyps are one of the main causes of infertility in women. In this work we propose an alternative, effective, economical and safe treatment: the use of misoprostol

Detailed Description

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The prevalence of uterine polyps has been estimated in the general population at 10-15%, while in infertile patients it ranges from 6-32%. Its etiology is considered as multifactorial. Polyps induce a local inflammatory response in the endometrial cavity, causing infertility. The treatment of choice considered "gold standard" is the excision by hysteroscopy, however, improvement has been shown in patients with conservative management due to the regression rate of 27%. There are no recommended drugs to provide a definitive treatment for uterine polyps. Misoprostol is a synthetic analogue derived from prostaglandin E1 that has stimulating effects on the smooth muscle fibers of the uterus, causing contractions of the myometrium, which cause endouterine evacuation. The present study shows a possible utility of misoprostol for the conservative treatment of uterine polyps.

Conditions

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Endometrial Polyps in Infertile Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Misoprostol

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

Interventions

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Misoprostol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women with uterine polyps diagnosed by endovaginal ultrasound and/or hysterosonography, female ≤ 45 years of age

Exclusion Criteria

* Patients older than 45 years, polyps larger than 60 mm, who did not perform surveillance and/or minimum assessment 6 months after medical management
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Henry Aristoteles Mate-Sánez

INDIV

Sponsor Role lead

Responsible Party

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Henry Aristoteles Mate-Sánez

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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HENRY A MATEO-SÁNEZ, MD

Role: STUDY_DIRECTOR

Henry Aristoteles Mate-Sánez

Other Identifiers

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MSP_2016

Identifier Type: -

Identifier Source: org_study_id

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