Abnormal Uterine Bleeding (AUB)NCT07731581
Pipelle Versus Manual Vacuum Aspiration Cannula for Endometrial Biopsy in Women With Abnormal Uterine Bleeding
A study testing Manual Vacuum Aspiration (MVA) Cannula and Pipelle Endometrial Suction Curette in people with Abnormal Uterine Bleeding (AUB), run by University of Health Sciences Lahore.
Trial summary
women globally, often requiring endometrial tissue sampling for accurate evaluation and diagnosis. Traditional office-based sampling techniques like Pipelle are widely used, but the disposable instruments can be relatively expensive in resource-limited settings. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Abnormal Uterine Bleeding (AUB)
- What is being tested?
- Manual Vacuum Aspiration (MVA) Cannula and Pipelle Endometrial Suction Curette
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2026to 12 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Married women aged 35 years and above.
- Presentation with abnormal uterine bleeding (AUB), including but not limited to metrorrhagia, menorrhagia, or postmenopausal bleeding.
- Clinical indication for endometrial sampling for diagnostic evaluation of abnormal uterine bleeding.
- Patient fit for both MVA and Pipelle procedures, with no contraindications to either method.
Who cannot join
- Pregnancy or suspicion of pregnancy.
- Acute pelvic inflammatory disease or active genital tract infection.
- Current use of anticoagulant therapy or presence of bleeding disorders that pose a risk for excessive bleeding during endometrial sampling.
About this study
Official title: A Comparative Study of Pipelle Versus Manual Vacuum Aspiration Cannula for Endometrial Biopsy
women globally, often requiring endometrial tissue sampling for accurate evaluation and diagnosis. Traditional office-based sampling techniques like Pipelle are widely used, but the disposable instruments can be relatively expensive in resource-limited settings. Manual Vacuum Aspiration (MVA) using a flexible cannula is an inexpensive, reusable alternative, but clinical data comparing its performance directly to Pipelle remains limited.
The objective of this randomized clinical trial is to compare Pipelle endometrial biopsy and Manual Vacuum Aspiration (MVA) cannula in terms of sample adequacy, patient satisfaction, and post-procedure complications in women presenting with abnormal uterine bleeding. Participants will be randomly assigned to undergo endometrial sampling using either a 4 mm MVA cannula or a Pipelle device without anesthesia or cervical dilation. Samples will be analyzed for histopathological diagnosis, and outcomes such as procedure pain, adequacy of tissue, and complications will be recorded.
- Conditions
- Abnormal Uterine Bleeding (AUB)
- Being tested
- Manual Vacuum Aspiration (MVA) Cannula, Pipelle Endometrial Suction Curette
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Vacuum Aspiration (MVA) CannulaOther
Endometrial sampling using a 4 mm flexible polyethylene MVA cannula connected to a manual vacuum aspiration syringe without dilation or anesthesia.
Pipelle Endometrial Suction CuretteOther
Endometrial biopsy using a flexible Pipelle device operated by pulling the internal piston to create negative pressure without dilation or anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group A: MVA Cannula | Active comparator | Participants assigned to Group A will undergo endometrial tissue sampling using a 4 mm Manual Vacuum Aspiration (MVA) cannula attached to an aspiration syringe without local anesthesia or cervical dilation under aseptic conditions. Receives: Other: Manual Vacuum Aspiration (MVA) Cannula |
| Group B: Pipelle Biopsy | Active comparator | Participants assigned to Group B will undergo endometrial sampling using a standard Pipelle device under aseptic conditions without local anesthesia or cervical dilation. The piston will be withdrawn to create vacuum-assisted suction and rotated to acquire tissue. Receives: Other: Pipelle Endometrial Suction Curette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Yield for Endometrial Pathology
Proportion of patients receiving a definitive histopathological diagnosis (differentiating benign vs. malignant/premalignant conditions) based on microscopic evaluation by a blinded consultant histopathologist.
Measured: At the time of histopathological assessment (within 7 days post-procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start11 Aug 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion12 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine Bleeding (AUB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR. IZAM AFZAL, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731581
- Sponsor's protocol ID
- Exp142
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided