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Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Unknown
Phase 4

Conditions

Hysteroscopy

Treatments

Drug: placebo
Drug: vaginal dinoprostone

Study type

Interventional

Funder types

Other

Identifiers

NCT04042974
dinoprostone hysteroscopy

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

15 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

dinoprostone
Experimental group
Description:
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
Treatment:
Drug: vaginal dinoprostone
placebo
Placebo Comparator group
Description:
one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
Treatment:
Drug: placebo

Trial contacts and locations

0

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Central trial contact

AHMED SAMY, MD

Data sourced from clinicaltrials.gov

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