SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF

NCT04415489 | Completed Results DMC FDA Device

• 1 other identifier: 18-3077
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine cavity evaluation. While hysteroscopy is regarded as the gold standard for diagnosis of intra-uterine pathology, it is not often used as an initial screening tool because of provider concerns about in-office tolerability, operating room costs, and use of anesthesia. The investigators aim to compare SIS and office hysteroscopy with respect to patient and provider satisfaction. Additionally, the investigators aim to assess the capability of office-based hysteroscopy to manage intra-uterine pathology at the time of diagnosis and reduce delays and supernumerary procedures.

Conditions

Infertility

Keywords

Assisted Reproduction

Outcome Measures

Primary Outcomes (3)

• Patient Satisfaction

  Survey with Likert scale administered to record patients overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).

  Immediately following imaging modality (less than 30 minutes)

• Pain Scores

  Survey administered to record patients pain scores during their procedure. Score range is 1-10, with one being minimal pain (better) and 10 being the worst pain ever experienced (worse).

  Immediately following imaging modality (less than 30 minutes)

• Provider Satisfaction

  Survey with Likert scale administered to record providers overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).

  Immediately following imaging modality (less than 30 minutes)

Secondary Outcomes (5)

• Time to Complete

  During the allotted procedure only

• Number of Patients Requiring Secondary Procedure

  Through study completion, up to 1 year

• Time to Infertility Treatment

  Through study completion, up to 1 year

• Positive Predictive Value of SIS

  Through study completion, up to 1 year

• Ability to Manage Pathology With Office Hysteroscopy

  During the allotted procedure only

Study Arms (2)

Office Hysteroscopy

ACTIVE COMPARATOR

Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.

Device: Office hysteroscopy

Saline Infusion Sonography (SIS)

NO INTERVENTION

This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.

Interventions

Office hysteroscopy DEVICE

Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.

Also known as: LiNA OperaScope

Office Hysteroscopy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 - 50
• Patients undergoing routine cavity evaluation for planned in vitro-fertilization cycles

You may not qualify if:

• Clinical or radiologic suspicion of intrauterine pathology including myomas, severe intrauterine adhesions or retained products of conception
• Those with medical criteria not suitable office hysteroscopy due to requirement of advanced tools or preparation not available in the office such as history of bleeding disorder or medical co-morbidity

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Fertility

Raleigh, North Carolina, 27616, United States

Location

Related Publications (1)

• Moustafa S, Rosen E, Goodman L. Patient and provider satisfaction with saline ultrasound versus office hysteroscopy for uterine cavity evaluation prior to in vitro fertilization: a randomized controlled trial. J Assist Reprod Genet. 2021 Mar;38(3):627-634. doi: 10.1007/s10815-021-02065-9. Epub 2021 Feb 1.

  PMID: 33527249 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Sarah Moustafa, MD
• Organization: University of North Carolina at Chapel Hill

sarah_moustafa@med.unc.edu

919-908-0000

Study Officials

• Sarah Moustafa, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Linnea Goodman, MD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial comparing satisfaction between saline infusion sonography and office hysteroscopy for screening evaluation of the uterine cavity prior to embryo transfer.

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: December 6, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 19, 2021
• Results First Posted: April 14, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 9 months and ending 3 years following article publication.
• Access Criteria: Investigator proposing to use data has IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC.

Locations

US (1)