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Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04270994
Recruitment Status : Completed
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Henry Aristoteles Mate-Sánez, Mateo-Sánez, Henry A.

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

Condition or disease Intervention/treatment Phase
Endometrial Polyps in Infertile Patients Drug: Misoprostol Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Misoprotol as a Treatment for Endometrial Polyps in Infertile Patients
Actual Study Start Date : September 2016
Actual Primary Completion Date : August 2019
Actual Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: Misoprostol Drug: Misoprostol



Primary Outcome Measures :
  1. Expulsion rate of endometrial polyps [ Time Frame: 7 days after misoprostol has been applied ]

Secondary Outcome Measures :
  1. Pregnancy rate after expulsion [ Time Frame: 14-21 days after positive β-human Chorionic Gonadotropin (β-hCG) ]
  2. The pregnancy rate after expulsion in patients with primary sterility [ Time Frame: 14-21 days after positive β-hCG ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04270994


Sponsors and Collaborators
Henry Aristoteles Mate-Sánez
Investigators
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Study Director: HENRY A MATEO-SÁNEZ, MD Henry Aristoteles Mate-Sánez

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Responsible Party: Henry Aristoteles Mate-Sánez, Principal Investigator, Mateo-Sánez, Henry A.
ClinicalTrials.gov Identifier: NCT04270994    
Other Study ID Numbers: MSP_2016
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Neoplasms
Infertility
Polyps
Pathological Conditions, Anatomical
Genital Diseases, Male
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics