Misoprostol Before Hysteroscopy in Infertile Cases

Overview

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.

Full Title of Study: “Effectiveness of Oral Versus Vaginal Misoprostol Before Office Hyteroscopy in Infertile Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2016

Interventions

  • Drug: Misoprostol , Prostaglandins E1 analogue

Arms, Groups and Cohorts

  • Experimental: Oral Misoprostol
    • 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.
  • Experimental: Vaginal Misoprostol
    • 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)
  • Placebo Comparator: Placebo
    • oral placebo (one pill every 8 hours) will be administered starting 24 hours before the office hysteroscopy.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Kasr El Aini Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yomna Ali Bayoumi, Lecturer of Obstetrics and Gynecology – Kasr El Aini Hospital
  • Overall Official(s)
    • Yomna A Bayoumi, MD, Principal Investigator, Kasr El Aini Hospital
  • Overall Contact(s)
    • Yomna A Bayoumi, MD, 01066812955, dryomnabayoumi@gmail.com

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