Misoprostol Before Hysteroscopy in Infertile Cases

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Misoprostol , Prostaglandins E1 analogue


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Misoprostol<br>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. | Drug: Misoprostol , Prostaglandins E1 analogue<br> <br> * Other names: Misotac;|
| Experimental: Vaginal Misoprostol<br>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) | Drug: Misoprostol , Prostaglandins E1 analogue<br> <br> * Other names: Misotac;|
| Placebo Comparator: Placebo<br>oral placebo (one pill every 8 hours) will be administered starting 24 hours before the office hysteroscopy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 months |