Skip to content

Relief of Pain and Tubal Spasm During Hysterosalpingogram in Infertile Women, a Randomized Controlled Trial of Diclofenac with Hyoscine versus Diclofenac Only.

Relief of Pain and Tubal Spasm During Hysterosalpingogram in Infertile Women, a Randomized Controlled Trial of Diclofenac with Hyoscine versus Diclofenac Only.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202508901076970
Enrollment
138
Registered
2025-08-21
Start date
2020-11-10
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility-female

Interventions

Group A. 50mg oral diclofenac potassium and and 20mg intramuscular hyoscine
Group B. 50mg oral diclofenac potassium and sterile water for injection water

Sponsors

Ojie Chukwunekwu Victory
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: These were women requiring HSG for evaluation of infertility, and who consented to participate in the study. Infertile women undergoing HSG investigations for the first time (i.e. had no prior experience of the pains associated with the procedure). those with no cognitive or visual impairment (and hence will not have difficulty understanding or completing the assessment tools). Patients who are at least 18 years of age.

Exclusion criteria

Exclusion criteria: Women who have documented allergy or known hypersensitivity to diclofenac potassium, hyoscine or urografin dye, known gastroesophageal disease, known cervical stenosis, presence of acute pelvic inflammatory disease, Active cervical lesion or endometrial infection, vaginal bleeding, or known reproductive tract malignancy.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure was the severity of pain in both study arms determined using the visual analogue score

Secondary

MeasureTime frame
The secondary outcome measures were an impression of cornnual spasm on radiological image assessment, patient satisfaction assessed at 30 minutes post-procedure, measured with a validated satisfaction survey, and the adverse effects of the medications experienced by women (nausea, vomiting, fainting, headache, hypotension).

Countries

Nigeria

Contacts

Public ContactChukwunekwu Ojie

Consultant Obstetrician and Gynaecologist Central Hospital Warri Delta State Nigeria

chukwunekwuoj@yahoo.com+2347033757224

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026