Comparison of 3D Transvaginal Ultrasonography and Diagnostic Hysteroscopy in detection of uterine abnormalities in women undergoing advanced fertility treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To compare the findings of Diagnostic Hysteroscopy and 3D Transvaginal Ultrasonography for detection of uterine abnormalities in women with subfertility.
Study Overview
Brief Summary
The study will be conducted in Wardha Test Tube Baby centrein AVBRH, Sawangi Meghe, Wardha. Baseline blood investigations and hormonal profile of the subjects will be done.
All women satisfying the inclusion criteria will be subjected to 2D Transvaginal Ultrasound followed by 3D Transvaginal Ultrasonography in follicular phase, after informed consent and thorough history and physical examination. Subjects will then be posted for Hysteroscopy after obtaining fitness for surgery. Intra-operative findings will be noted.
The 3D Transvaginal Ultrasonography and Hysteroscopy will be performed independently by two separate individuals and the respective findings will not be shared between the observers. The data will be analysed and diagnostic accuracy of both the procedures will be calculated and compared.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 21.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women with primary of secondary infertility undergoing advanced fertility treatments like IUI and IVF , consenting for 3D transvaginal ultrasonography and Diagnostic Hysteroscopy.
Exclusion Criteria
- •Patients with already diagnosed uterine abnormalities.
- •Cervical stenosis.
- •Inability to perform Hysteroscopy due to any contraindication.
- •Current STI/ PID.
Outcomes
Primary Outcomes
To compare the findings of Diagnostic Hysteroscopy and 3D Transvaginal Ultrasonography for detection of uterine abnormalities in women with subfertility.
Time Frame: baseline
Secondary Outcomes
- To compare the diagnostic accuracy of 3D Transvaginal Ultrasonography with Diagnostic Hysteroscopy in detecting uterine abnormalities in women with subfertility taking advanced fertility treatment.(baseline)
Investigators
Nova Shinde
Datta Meghe Institute of Higher Education and Research