ClinicalTrials.gg
Not yet recruitingNCT07731581Updated Jul 28, 2026

Pipelle Versus Manual Vacuum Aspiration Cannula for Endometrial Biopsy in Women With Abnormal Uterine Bleeding

An interventional study of Manual Vacuum Aspiration (MVA) Cannula and Pipelle Endometrial Suction Curette in Abnormal Uterine Bleeding (AUB), sponsored by University of Health Sciences Lahore. Not yet recruiting. Open to female participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.

Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
35 Years and older
Sex
Female
01

Study 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. 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.

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Conditions studied

  • Abnormal Uterine Bleeding (AUB)

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03

In context

Metrorrhagia

153 studies on the registry are indexed under Metrorrhagia; 35 are open to participants now.

This study's planned enrollment of 80 is below the median of 100 across 115 interventional studies indexed under Metrorrhagia.

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Lead sponsor

University of Health Sciences Lahore is the lead sponsor of 83 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Married women aged 35 years and above.
  2. Presentation with abnormal uterine bleeding (AUB), including but not limited to metrorrhagia, menorrhagia, or bleeding.
  3. Clinical indication for endometrial sampling for diagnostic evaluation of abnormal uterine bleeding.
  4. Patient fit for both MVA and Pipelle procedures, with no to either method.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy or suspicion of pregnancy.
  2. Acute pelvic inflammatory disease or active genital tract infection.
  3. Current use of anticoagulant therapy or presence of bleeding disorders that pose a risk for excessive bleeding during endometrial sampling.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Group A: MVA Cannula

    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.

    Other: Manual Vacuum Aspiration (MVA) Cannula

  • Active comparator
    Group B: Pipelle Biopsy

    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.

    Other: Pipelle Endometrial Suction Curette

Interventions

  • OtherManual Vacuum Aspiration (MVA) Cannula

    Endometrial sampling using a 4 mm flexible polyethylene MVA cannula connected to a manual vacuum aspiration syringe without dilation or anesthesia.

  • OtherPipelle Endometrial Suction Curette

    Endometrial biopsy using a flexible Pipelle device operated by pulling the internal piston to create negative pressure without dilation or anesthesia.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the time of histopathological assessment (within 7 days post-procedure)

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Feb 2027, 6 months later.

Of 41 non-industry interventional studies with no phase under Metrorrhagia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's planned 6 months is below that.

Counting every sponsor, half of 43 studies reached it within 17 months; a quarter within 6 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2026
First posted
Jul 28, 2026
StartEst.
Aug 11, 2026
Primary completionEst.
Feb 15, 2027
CompletionEst.
Aug 12, 2027
Last update
Jul 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07731581
Lead sponsor
University of Health Sciences Lahore
Responsible party
DR. IZAM AFZAL (Principle Investigator, University of Health Sciences Lahore) — Principal investigator
First posted
Jul 28, 2026
Start date
Aug 11, 2026 (estimated)
Primary completion
Feb 15, 2027 (estimated)
Completion
Aug 12, 2027 (estimated)
Last update
Jul 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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