Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients

Endometrial Polyps in Infertile Patients Clinical Trial

Official title:

Misoprotol as a Treatment for Endometrial Polyps in Infertile Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04270994
• Other study ID #: MSP_2016
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2016
• Est. completion date: November 2019

Study information

• Verified date: February 2020
• Source: Mateo-Sánez, Henry A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Polyps in Infertile Patients
• Infertility
• Polyps
• Uterine Neoplasms

Intervention

Drug:
• Misoprostol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henry Aristoteles Mate-Sánez

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expulsion rate of endometrial polyps		7 days after misoprostol has been applied
Secondary	Pregnancy rate after expulsion		14-21 days after positive ß-human Chorionic Gonadotropin (ß-hCG)
Secondary	The pregnancy rate after expulsion in patients with primary sterility		14-21 days after positive ß-hCG