Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

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

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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