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
About this trial
This is an interventional treatment trial for Endometrial Polyps in Infertile Patients
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
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
NCT ID
NCT04270994
First Posted
February 10, 2020
Last Updated
February 13, 2020
Sponsor
Henry Aristoteles Mate-Sánez
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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