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Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients

Primary Purpose

Endometrial Polyps in Infertile Patients

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
Henry Aristoteles Mate-Sánez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Polyps in Infertile Patients

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Misoprostol

    Arm Description

    Outcomes

    Primary Outcome Measures

    Expulsion rate of endometrial polyps

    Secondary Outcome Measures

    Pregnancy rate after expulsion
    The pregnancy rate after expulsion in patients with primary sterility

    Full Information

    First Posted
    February 10, 2020
    Last Updated
    February 13, 2020
    Sponsor
    Henry Aristoteles Mate-Sánez
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04270994
    Brief Title
    Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients
    Official Title
    Misoprotol as a Treatment for Endometrial Polyps in Infertile Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    August 2019 (Actual)
    Study Completion Date
    November 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Henry Aristoteles Mate-Sánez

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometrial Polyps in Infertile Patients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Misoprostol
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Misoprostol
    Primary Outcome Measure Information:
    Title
    Expulsion rate of endometrial polyps
    Time Frame
    7 days after misoprostol has been applied
    Secondary Outcome Measure Information:
    Title
    Pregnancy rate after expulsion
    Time Frame
    14-21 days after positive β-human Chorionic Gonadotropin (β-hCG)
    Title
    The pregnancy rate after expulsion in patients with primary sterility
    Time Frame
    14-21 days after positive β-hCG

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    HENRY A MATEO-SÁNEZ, MD
    Organizational Affiliation
    Henry Aristoteles Mate-Sánez
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients

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