Endometrial Polyps in Infertile PatientsPhase 2/3NCT04270994
Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients
A Phase 2/3 study testing Misoprostol in people with Endometrial Polyps in Infertile Patients, run by Henry Aristoteles Mate-Sánez.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometrial Polyps in Infertile Patients
- What is being tested?
- Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Nov 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with uterine polyps diagnosed by endovaginal ultrasound and/or hysterosonography, female ≤ 45 years of age
Who cannot join
- Patients older than 45 years, polyps larger than 60 mm, who did not perform surveillance and/or minimum assessment 6 months after medical management
About this study
Official title: 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
Read the 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.
- Conditions
- Endometrial Polyps in Infertile Patients
- Being tested
- Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | Not described Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expulsion rate of endometrial polyps
Measured: 7 days after misoprostol has been applied
Secondary outcomes (2)
Pregnancy rate after expulsion
Measured: 14-21 days after positive β-human Chorionic Gonadotropin (β-hCG)
The pregnancy rate after expulsion in patients with primary sterility
Measured: 14-21 days after positive β-hCG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study startSep 2016
- Primary completionAug 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Polyps in Infertile PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Aristoteles Mate-Sánez
- Responsible party
- Sponsor-investigator, Henry Aristoteles Mate-Sánez, Mateo-Sánez, Henry A.
- Investigators
- HENRY A MATEO-SÁNEZ, MD, Study director, Henry Aristoteles Mate-Sánez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270994
- Sponsor's protocol ID
- MSP_2016
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprotol as a Treatment for Endometrial Polyps in Infertile Patients
- ClinicalTrials.gov ID
- NCT04270994
- Acronym / sponsor ID
- MSP_2016
- Conditions
- Endometrial Polyps in Infertile Patients
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Henry Aristoteles Mate-Sánez
- Study start
- Sep 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: Misoprostol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with uterine polyps diagnosed by endovaginal ultrasound and/or hysterosonography, female ≤ 45 years of age
Key exclusion criteria (1 listed)
- Patients older than 45 years, polyps larger than 60 mm, who did not perform surveillance and/or minimum assessment 6 months after medical management
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol | Drug | Misoprostol |
Primary outcome
Expulsion rate of endometrial polyps
Time frame: 7 days after misoprostol has been applied
2 secondary outcomes
Pregnancy rate after expulsion
Time frame: 14-21 days after positive β-human Chorionic Gonadotropin (β-hCG)
The pregnancy rate after expulsion in patients with primary sterility
Time frame: 14-21 days after positive β-hCG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HENRY A MATEO-SÁNEZ, MD study director
Henry Aristoteles Mate-Sánez
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Misoprostol in people with Endometrial Polyps in Infertile Patients, run by Henry Aristoteles Mate-Sánez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expulsion rate of endometrial polyps (time frame: 7 days after misoprostol has been applied). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.