Misoprostol Before Hysteroscopy in Infertile Cases

Kasr El Aini Hospital

Status and phase: Unknown; Phase 2

Conditions: Infertility

Treatments: Drug: Misoprostol , Prostaglandins E1 analogue

Study type: Interventional

Funder types: Other

Identifiers

NCT02409407

MS20150303

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups, including a placebo group

Oral Misoprostol

Experimental group

Description:

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.

Treatment:

Drug: Misoprostol , Prostaglandins E1 analogue

Vaginal Misoprostol

Experimental group

Description:

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)

Treatment:

Drug: Misoprostol , Prostaglandins E1 analogue

Placebo

Placebo Comparator group

Description:

oral placebo (one pill every 8 hours) will be administered starting 24 hours before the office hysteroscopy.