Tubal Flushing Using Water Soluble Media for Unexplained Infertility
1 other identifier
interventional
300
1 country
2
Brief Summary
300 women with unexplained infertility will be randomly divided into 2 equal groups: Group 1 will be offered tubal flushing with water soluble media through hysterosalpingography (HSG) and group 2 will receive no intervention
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2015
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 23, 2017
January 1, 2017
2.6 years
April 24, 2015
January 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pregnancy
Pregnancy will be defined as the presence of an intrauterine sac by vaginal ultrasound
Monthly, up to 12 months
Study Arms (2)
Tubal flushing with Urografin®
ACTIVE COMPARATORWomen will have HSG using water soluble media
Control group
NO INTERVENTIONWomen will not receive any intervention
Interventions
Women will have tubal flushing through HSG using water soluble media (Urographin ®)
Women will receive oral diclofenac 50 mg (voltaren ®) 1 hour before hysterosalpingography
Eligibility Criteria
You may qualify if:
- infertility for one year
- Normal semen analysis
- Normal ovulation
You may not qualify if:
- Allergy to Iodine
- Metformin therapy
- Tubal block
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (2)
BeniSuef University hospitals
BeniSuef, Egypt
Cairo University Hospitals
Cairo, Egypt
Related Publications (4)
Steiner AZ, Meyer WR, Clark RL, Hartmann KE. Oil-soluble contrast during hysterosalpingography in women with proven tubal patency. Obstet Gynecol. 2003 Jan;101(1):109-13. doi: 10.1016/s0029-7844(02)02390-6.
PMID: 12517654BACKGROUNDSpring DB, Barkan HE, Pruyn SC. Potential therapeutic effects of contrast materials in hysterosalpingography: a prospective randomized clinical trial. Kaiser Permanente Infertility Work Group. Radiology. 2000 Jan;214(1):53-7. doi: 10.1148/radiology.214.1.r00ja2353.
PMID: 10644101BACKGROUNDLuttjeboer F, Harada T, Hughes E, Johnson N, Lilford R, Mol BW. Tubal flushing for subfertility. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003718. doi: 10.1002/14651858.CD003718.pub3.
PMID: 17636730BACKGROUNDWang R, Watson A, Johnson N, Cheung K, Fitzgerald C, Mol BWJ, Mohiyiddeen L. Tubal flushing for subfertility. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD003718. doi: 10.1002/14651858.CD003718.pub5.
PMID: 33053612DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Gynecology and Obstetrics
Study Record Dates
First Submitted
April 24, 2015
First Posted
May 5, 2015
Study Start
May 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
January 23, 2017
Record last verified: 2017-01