NCT03604549

Brief Summary

Performing fluoroscopic HSG with oil based contrast medium has been shown to increase pregnancy rates in a subfertile population. This is a pilot study to test the efficacy of as well as the tolerability and safety of using lipid based oil medium for sonographic based hysterosalpingography (Sono HSG) compared to water based contrast (i.e. normal saline) for women seeking fertility. The double blind study will randomize 56 women at the time of Sono HSG in a 1:1 ratio to receive through the SHG catheter either up to 10 cc of Lipiodol UF® or normal saline. The investigators will collect subjective pain experience and follow the subjects for 6 months after the test for pregnancy and collect all adverse events during and after the procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

January 11, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2021

Completed
6 months until next milestone

Results Posted

Study results publicly available

February 24, 2022

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

2.4 years

First QC Date

July 10, 2018

Results QC Date

February 3, 2022

Last Update Submit

April 4, 2022

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Ongoing Pregnancy Rate

    8 week viable intrauterine pregnancy

    within 6 months of Sono HSG procedure

Secondary Outcomes (1)

  • Procedural Related Pain Assessed by Visual Analog Scale

    After sono hystersalpingography study infusion/procedure completed

Study Arms (2)

Saline

PLACEBO COMPARATOR

Women in this arm will receive a flush with saline after normal saline Sono HSG.

Drug: Saline

Lipiodol UF

EXPERIMENTAL

Women in this arm will receive a flush with Lipiodol UF after normal saline Sono HSG.

Drug: Lipiodol UF

Interventions

Lipiodol UFDRUG

Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter

Also known as: Lipiodol Ultra Fluid
Lipiodol UF
SalineDRUG

Up to 10cc of saline will be infused via intrauterine catheter

Saline

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Eligible for Sono HSG for fertility testing
  • In good general health
  • Willing and capable of complying with the study procedures
  • At least one patent tube and no endometrial pathology on Sono HSG
  • Ready to undergo infertility treatment immediately after the test
  • Not planning on IVF therapy in the next 6 mos

You may not qualify if:

  • Known tubal or endometrial (polyp, submucous fibroid, etc.) pathology
  • At high risk for tubal disease due to history of Pelvic Inflammatory Disease
  • Known hypersensitivity to Lipiodol UF®or known allergy to iodine containing contrast media or shellfish
  • Endometrial pathology on Sono HSG requiring further evaluation (as per the performing physician)
  • Bilateral tubal occlusion on Sono HSG
  • Unable to tolerate potential pain associated with the study.
  • Requiring IVF due to severe male factor, known pelvic adhesions, etc.
  • Couples with decreased male factor fertility rate (i.e., low sperm count or motility, i.e. less than 5 million/mL concentration on semen analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Wang 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

Infertility

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Richard S. Legro, M.D., Principal Investigator
Organization
Penn State Health Milton S. Hershey Medical Center
rsl1@psu.edu
717-531-6210

Study Officials

  • Richard Legro, M.D.

    Penn State University and Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interim Chair and Vice Chair of Research, Department of Obstetrics and Gynecology, Professor of Obstetrics and Gynecology and Public Health Sciences

Study Record Dates

First Submitted

July 10, 2018

First Posted

July 27, 2018

Study Start

January 11, 2019

Primary Completion

May 31, 2021

Study Completion

August 25, 2021

Last Updated

May 2, 2022

Results First Posted

February 24, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)