Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients
Primary Purpose
Hysteroscopy
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
vaginal dinoprostone
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hysteroscopy
Eligibility Criteria
Inclusion Criteria:
- nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup
Exclusion Criteria:
• women with suspected pregnancy
- heavy vaginal bleeding
- recent pelvic infection
- those known to have hypersensitivity or contraindication to dinoprostone
- those who received analgesics prior to OH
- a concomitant neurologic disease that could affect the correct evaluation of pain
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
dinoprostone
placebo
Arm Description
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
Outcomes
Primary Outcome Measures
Intensity of pain
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10
Secondary Outcome Measures
Intensity of pain
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
Operative time
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04042974
Brief Title
Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients
Official Title
Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients:a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2019 (Anticipated)
Primary Completion Date
November 10, 2019 (Anticipated)
Study Completion Date
November 20, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To compare the effectiveness of vaginal dinoprostone with placebo in minimizing the pain experienced by primarily infertile patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.
Detailed Description
hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes. The most commonly used agent is misoprostol, a synthetic prostaglandin E1 (PGE1) analog that is frequently administered in off-label use in obstetrics and gynecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening. In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysteroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dinoprostone
Arm Type
Experimental
Arm Description
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
Intervention Type
Drug
Intervention Name(s)
vaginal dinoprostone
Intervention Description
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
Primary Outcome Measure Information:
Title
Intensity of pain
Description
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10
Time Frame
an expected average of 10 minutes
Secondary Outcome Measure Information:
Title
Intensity of pain
Description
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
Time Frame
30 minutes after the procedure
Title
Operative time
Description
From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
Time Frame
an expected average 10 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup
Exclusion Criteria:
• women with suspected pregnancy
heavy vaginal bleeding
recent pelvic infection
those known to have hypersensitivity or contraindication to dinoprostone
those who received analgesics prior to OH
a concomitant neurologic disease that could affect the correct evaluation of pain
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AHMED SAMY, MD
Phone
+201100681167
Email
ahmedsamy8233@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED SAMY, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients
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