N/A
Completed N=100
SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF
Source: ClinicalTrials.gov NCT04415489 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Patient Satisfaction — 4.92; 4.84 units on a scale — p=0.57
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Satisfaction |
4.92; 4.84 | 0.57 |
| PRIMARY Pain Scores |
3.38; 2.44 | <0.01 sig |
| PRIMARY Provider Satisfaction |
4.76; 4.56 | 0.11 |
| SECONDARY Time to Complete |
4.61; 3.98 | 0.16 |
| SECONDARY Number of Patients Requiring Secondary Procedure |
1; 11 | < 0.01 sig |
| SECONDARY Time to Infertility Treatment |
— | — |
| SECONDARY Positive Predictive Value of SIS |
9 | — |
| SECONDARY Ability to Manage Pathology With Office Hysteroscopy |
16 | — |
Eligibility Criteria
Inclusion Criteria
- Women aged 18 - 50
- Patients undergoing routine cavity evaluation for planned in vitro-fertilization cycles
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04415489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.