Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

Study Overview
=================
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.

Official Title
-----------------
Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients:a Randomized Controlled Trial

Conditions
-----------------
Hysteroscopy

Intervention / Treatment
-----------------
* Drug: vaginal dinoprostone
* Drug: placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dinoprostone<br>1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy. | Drug: vaginal dinoprostone<br>* 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.<br>|
| Placebo Comparator: placebo<br>one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy. | Drug: placebo<br>* one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain | Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10 | an expected average of 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 minutes after the procedure | 
| Operative time | From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination | an expected average 10 minutes |