Misoprostol Before Hysteroscopy in Infertile Cases

NCT02409407 | Unknown Phase 2

• 1 other identifier: MS20150303
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Oral Misoprostol

EXPERIMENTAL

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

Vaginal Misoprostol

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Misoprostol , Prostaglandins E1 analogue DRUG

Also known as: Misotac

Oral Misoprostol; Vaginal Misoprostol

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr el Ainy hospital

Cairo, Cairo Governorate, 12211, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Yomna A Bayoumi, MD

  Kasr El Aini Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yomna A Bayoumi, MD

CONTACT

01066812955; dryomnabayoumi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 6, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 6, 2015

Record last verified: 2015-04

Locations

EG (1)