Misoprostol Before Hysteroscopy in Infertile Cases

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02409407
• Other study ID #: MS20150303
• Status: Recruiting
• Phase: Phase 2
• First received: April 1, 2015
• Last updated: April 3, 2015
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: April 2015
• Source: Kasr El Aini Hospital
• Contact: Yomna A Bayoumi, MD
• Phone: 01066812955
• Email: dryomnabayoumi[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Misoprostol , Prostaglandins E1 analogue

Locations

Country	Name	City	State
Egypt	Kasr el Ainy hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No