InfertilityPhase 2NCT02409407
Misoprostol Before Hysteroscopy in Infertile Cases
A Phase 2 study testing Misoprostol , Prostaglandins E1 analogue in people with Infertility, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The role of hysteroscopy in infertility investigation is to detect possible intrauterine changes that could interfere with implantation or growth or both of the conceptus, with the invention of miniature hysteroscope, it is possible to perform hysteroscopy in an office setting (Outpatient hysteroscopy; OH), for… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Misoprostol , Prostaglandins E1 analogue
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to May 2016
- Phase
- Phase 2
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients aged from 20 to 40 years old.
- They are complaining with primary or secondary infertility.
- They undergo investigations including husband semen analysis, hormonal assay, U/S, Hystrosalpingography.
Who cannot join
- Known sensitivity to misoprostol.
- Any systemic disease contraindicating the use of prostaglandins (cardiovascular disease, hypertension, renal failure, etc).
- Concomitant neurologic disease that could affect the correct evaluation of pain.
- Pregnancy.
- Any contraindication to hysteroscopy such as Pelvic inflammatory disease (PID).
- Heavy uterine bleeding.
- Any uterine abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr el Ainy hospital
Cairo, Cairo Governorate, 12211
Yomna A Bayoumi, MD, 01066812955 ext. 002, dryomnabayoumi@gmail.com
Yomna A Bayoumi, MD
About this study
Official title: Effectiveness of Oral Versus Vaginal Misoprostol Before Office Hyteroscopy in Infertile Patients
The role of hysteroscopy in infertility investigation is to detect possible intrauterine changes that could interfere with implantation or growth or both of the conceptus, with the invention of miniature hysteroscope, it is possible to perform hysteroscopy in an office setting (Outpatient hysteroscopy; OH), for diagnostic and certain therapeutic intervention. It is currently acknowledged as the 'gold standard' investigation of the intrauterine abnormalities.
Cervical priming prior to diagnostic hysteroscopy softens the cervix and lessens the force needed for dilation, thereby potentially reducing the probability of procedural complication such as uterine perforation, cervical laceration, failure to dilate, and creation of a false track that can occur during cervical entry.
Misoprostol is a prostaglandin El analogue, that can be administered either orally or vaginally, that can cause cervical ripening by inducing collagenolytic activity and synthesis of proteoglycans.
- Conditions
- Infertility
- Being tested
- Misoprostol , Prostaglandins E1 analogue
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol , Prostaglandins E1 analogueDrug
Also called Misotac
| Study group | Role | What they receive |
|---|---|---|
| Oral Misoprostol | Experimental | oral misoprostol ( prostaglandins E1 analogue) will be administered at a dose of 600 µg (200 µg every 8 hours), starting 24 hours before office hysteroscopy. Receives: Drug: Misoprostol , Prostaglandins E1 analogue |
| Vaginal Misoprostol | Experimental | vaginal misoprostol ( prostaglandins E1 analogue)will be administered at a dose of 400 µg (200 µg 12 hours apart, starting 24 hours before office hysteroscopy) Receives: Drug: Misoprostol , Prostaglandins E1 analogue |
| Placebo | Placebo comparator | oral placebo (one pill every 8 hours) will be administered starting 24 hours before the office hysteroscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of pelvic pain according to a 10-point visual analogue scale (VAS)
The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS). The VAS will be applied immediately after the procedure ended
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Ali Bayoumi, Kasr El Aini Hospital
- Investigators
- Yomna A Bayoumi, MD, Principal investigator, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409407
- Sponsor's protocol ID
- MS20150303
- Status last verified
- Apr 2015
- First submitted
- 1 Apr 2015
- Last updated
- 6 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Oral Versus Vaginal Misoprostol Before Office Hyteroscopy in Infertile Patients
- ClinicalTrials.gov ID
- NCT02409407
- Acronym / sponsor ID
- MS20150303
- Conditions
- Infertility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 6 Apr 2015 (estimated)
- 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.
The role of hysteroscopy in infertility investigation is to detect possible intrauterine changes that could interfere with implantation or growth or both of the conceptus, with the invention of miniature hysteroscope, it is possible to perform hysteroscopy in an office setting (Outpatient hysteroscopy; OH), for diagnostic and certain therapeutic intervention. It is currently acknowledged as the 'gold standard' investigation of the intrauterine abnormalities.
Cervical priming prior to diagnostic hysteroscopy softens the cervix and lessens the force needed for dilation, thereby potentially reducing the probability of procedural complication such as uterine perforation, cervical laceration, failure to dilate, and creation of a false track that can occur during cervical entry.
Misoprostol is a prostaglandin El analogue, that can be administered either orally or vaginally, that can cause cervical ripening by inducing collagenolytic activity and synthesis of proteoglycans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Misoprostol | Experimental | Drug: Misoprostol , Prostaglandins E1 analogueoral misoprostol ( prostaglandins E1 analogue) will be administered at a dose of 600 µg (200 µg every 8 hours), starting 24 hours before office hysteroscopy. |
| Vaginal Misoprostol | Experimental | Drug: Misoprostol , Prostaglandins E1 analoguevaginal misoprostol ( prostaglandins E1 analogue)will be administered at a dose of 400 µg (200 µg 12 hours apart, starting 24 hours before office hysteroscopy) |
| Placebo | Placebo comparator | –oral placebo (one pill every 8 hours) will be administered starting 24 hours before the office hysteroscopy. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients aged from 20 to 40 years old.
- They are complaining with primary or secondary infertility.
- They undergo investigations including husband semen analysis, hormonal assay, U/S, Hystrosalpingography.
Key exclusion criteria (7 listed)
- Known sensitivity to misoprostol.
- Any systemic disease contraindicating the use of prostaglandins (cardiovascular disease, hypertension, renal failure, etc).
- Concomitant neurologic disease that could affect the correct evaluation of pain.
- Pregnancy.
- Any contraindication to hysteroscopy such as Pelvic inflammatory disease (PID).
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 , Prostaglandins E1 analogueAlso: Misotac | Drug | Oral Misoprostol, Vaginal Misoprostol |
Primary outcome
level of pelvic pain according to a 10-point visual analogue scale (VAS)
Time frame: 10 months
The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS). The VAS will be applied immediately after the procedure ended
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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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.
Yomna A Bayoumi, MD principal investigator
Kasr El Aini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Misoprostol , Prostaglandins E1 analogue in people with Infertility, run by Kasr El Aini Hospital at 1 site in Egypt.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yomna A Bayoumi, MD (01066812955 ext. 002, dryomnabayoumi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of pelvic pain according to a 10-point visual analogue scale (VAS) (time frame: 10 months). 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 6 Apr 2015.