RecruitingPhase 2ACTRN12606000052538

Efficacy of endosampler as a tool for diagnosing endometriosis in comparison with endometrial currettage

Pilot study to evaluate the efficacy of endosampler as a tool for diagnosing endometriosis in comparison with endometrial currettage to identify endometrial nerve fibers by staining the obtained endometrial biopsies with Polyclonal rabbit anti-protein gene product (PGP9.5) of unmyelinated endometrial nerve fibres


Sponsor

Department of O&G Univesity of Sydney

Enrollment

20 participants

Start Date

Feb 1, 2006

Study Type

Interventional

Conditions

Summary

A research study into the gynaecological disease called endometriosis. Endometriosis affects 10 -15% of reproductive women. It can cause painful periods and painful intercourse, infertility and irregular bleeding. The cause of the disease is still unknown and the diagnosis of endometriosis is only possible with surgery. Women who are known to have endometriosis and those whose symptoms suggest that they may have endometriosis are being invited to participate in our study. The objective of our study is to investigate whether a device called Endosampler can be used to diagnose endometriosis by picking up small nerve fibres in the lining of the womb .Our preliminary studies suggest that these nerve fibres play a role in pain generation associated with endometriosis


Eligibility

Sex: FemalesMin Age: 15 YearssMax Age: 52 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a tool called an Endosampler can be used to diagnose endometriosis — a painful condition where tissue similar to the womb lining grows outside the womb. Right now, the only way to confirm endometriosis is through surgery. Researchers believe that testing tissue from inside the womb may reveal tiny nerve fibres linked to pain, which could offer a less invasive way to diagnose the condition. You may be eligible if: - You are a woman of reproductive age (between 15 and 52 years old) - You are known to have endometriosis and are not currently on any medical treatment for it - You are scheduled for a laparoscopy (keyhole surgery) to confirm endometriosis You may NOT be eligible if: - You are currently taking hormone treatments - You do not have endometriosis - You have had an endometrial ablation (procedure to remove the womb lining) - You have a history of cervical stenosis (narrowing of the cervix) - You do not wish to have the Endosampler procedure Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Two interventions will be done: 1- endometrial biopsy using MedGyn EndoSampler(Distributed by IPAS. Manufactured by MedGYn). 2-endometrial biopsy using curetting The Endosampler: Is a sterile d

Two interventions will be done: 1- endometrial biopsy using MedGyn EndoSampler(Distributed by IPAS. Manufactured by MedGYn). 2-endometrial biopsy using curetting The Endosampler: Is a sterile disposable curette for sampling endometrium aids to obtain differentiated endometrial tissue without anaesthesia. Except for rare instances it does not need cervical block. It has 3mm cannula with sharp sluts to ensure better sampling which attached to 10 mm syringe. This pilot study will be conducted by recruiting 20 women known to have endometriosis but not recently on treatment for endometriosis. Two questioners will be filled; one by the woman herself stating her past medical history and cycle history; other one will be filled by treating doctor documenting woman’s medical history, clinical and laboratory findings. After obtaining an informed consent from the woman, an endometrial biopsies will be obtained by endometrial curettage and endosampler in theater during laparoscopy and D&C usually within one month after obtaining consent. The two biopsies will be stained by PGP9.5 to look for endometrial nerve fibers. A comparison between the two biopsies will be done to see if endosampler is successful as endometrial curettage in identifying these nerve fibers.


Locations(1)

Australia

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ACTRN12606000052538


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