Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients

Misoprotol as a Treatment for Endometrial Polyps in Infertile Patients

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

Study Overview

• Status: Completed
• Conditions: Endometrial Polyps in Infertile Patients
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Misoprostol	Drug: Misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Expulsion rate of endometrial polyps	7 days after misoprostol has been applied

Secondary Outcome Measures

Outcome Measure	Time Frame
Pregnancy rate after expulsion	14-21 days after positive β-human Chorionic Gonadotropin (β-hCG)
The pregnancy rate after expulsion in patients with primary sterility	14-21 days after positive β-hCG

Collaborators and Investigators

• Sponsor: Henry Aristoteles Mate-Sánez
• Investigators: Study Director: HENRY A MATEO-SÁNEZ, MD, Henry Aristoteles Mate-Sánez

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Pathological Conditions, Anatomical; Infertility; Polyps; Uterine Neoplasms; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: MSP_2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No