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Misoprostol Before Hysteroscopy in Infertile Cases

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol , Prostaglandins E1 analogue
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Kasr el Ainy hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Oral Misoprostol

Vaginal Misoprostol

Placebo

Arm 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.

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 1, 2015
Last Updated
April 3, 2015
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02409407
Brief Title
Misoprostol Before Hysteroscopy in Infertile Cases
Official Title
Effectiveness of Oral Versus Vaginal Misoprostol Before Office Hyteroscopy in Infertile Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Misoprostol
Arm Type
Experimental
Arm 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.
Arm Title
Vaginal Misoprostol
Arm Type
Experimental
Arm 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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
oral placebo (one pill every 8 hours) will be administered starting 24 hours before the office hysteroscopy.
Intervention Type
Drug
Intervention Name(s)
Misoprostol , Prostaglandins E1 analogue
Other Intervention Name(s)
Misotac
Primary Outcome Measure Information:
Title
level of pelvic pain according to a 10-point visual analogue scale (VAS)
Description
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
Time Frame
10 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yomna A Bayoumi, MD
Phone
01066812955
Ext
002
Email
dryomnabayoumi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yomna A Bayoumi, MD
Organizational Affiliation
Kasr El Aini Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr el Ainy hospital
City
Cairo
ZIP/Postal Code
12211
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yomna A Bayoumi, MD
Phone
01066812955
Ext
002
Email
dryomnabayoumi@gmail.com
First Name & Middle Initial & Last Name & Degree
Yomna A Bayoumi, MD

12. IPD Sharing Statement

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Misoprostol Before Hysteroscopy in Infertile Cases

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