Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients

Phase 2

Completed

• Conditions: Endometrial Polyps in Infertile Patients
• Interventions: Drug: Misoprostol

• Registration Number: NCT04270994
• Lead Sponsor: Henry Aristoteles Mate-Sánez

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.

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2019-08
• Study Completion: 2019-11
• Status Verified: 2020-02
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-13
• Last Update Submitted: 2020-02-13
• Study First Posted: 2020-02-17
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Misoprostol	Misoprostol	-

Primary Outcome Measures

Name	Time	Method
Expulsion rate of endometrial polyps	7 days after misoprostol has been applied

Secondary Outcome Measures

Name	Time	Method
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