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Misoprostol Before Hysteroscopy in Infertile Cases

Effectiveness of Oral Versus Vaginal Misoprostol Before Office Hyteroscopy in Infertile Patients

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02409407
Enrollment
120
Registered
2015-04-06
Start date
2015-04-30
Completion date
2016-05-31
Last updated
2015-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief 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 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.

Interventions

DRUGMisoprostol , Prostaglandins E1 analogue

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
level of pelvic pain according to a 10-point visual analogue scale (VAS)10 monthsThe 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

Countries

Egypt

Contacts

Primary ContactYomna A Bayoumi, MD
dryomnabayoumi@gmail.com01066812955

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026