Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

NCT ID: NCT04042974

Last Updated: 2019-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-10
• Study Completion Date: 2019-11-20

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.

Conditions

Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dinoprostone

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

Group Type: EXPERIMENTAL

vaginal dinoprostone

Intervention Type: DRUG

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

placebo

one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Interventions

vaginal dinoprostone

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

placebo

one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Intervention Type: DRUG

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED SAMY, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

AHMED SAMY, MD

Role: CONTACT

ahmedsamy8233@gmail.com

+201100681167

Other Identifiers

dinoprostone hysteroscopy

Identifier Type: -

Identifier Source: org_study_id