Misoprostol Before Hysteroscopy in Infertile Cases

Phase 2

• Conditions: Infertility
• Interventions: Drug: Misoprostol , Prostaglandins E1 analogue

• Registration Number: NCT02409407
• Lead Sponsor: Kasr El Aini Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-04
• Study Start: 2015-04
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-04-03
• Last Update Submitted: 2015-04-03
• Study First Posted: 2015-04-06
• Last Update Posted: 2015-04-06
• Primary Completion: 2016-04
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Misoprostol	Misoprostol , Prostaglandins E1 analogue	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.
Vaginal Misoprostol	Misoprostol , Prostaglandins E1 analogue	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)

Primary Outcome Measures

Name	Time	Method
level of pelvic pain according to a 10-point visual analogue scale (VAS)	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

Trial Locations

Locations (1)

Kasr el Ainy hospital; 🇪🇬 Cairo, Egypt