None listed
Conditions
Brief 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
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 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
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.
Sponsors
Department of O&G Univesity of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to 52 Years
Healthy volunteers
No
Inclusion criteria
1-Women in any reproductive age.2-Women known to have endometriosis but not receiving any medical treatment.3-Women undergoing laparoscopy to confirm endometriosis.
Exclusion criteria
1-Women on hormonal treatment.2-Women not having endometriosis.3-Women underwent endometrial ablation.4-Women with history of cervical stenosis.5-Women refusing to have endosampler.
Outcome results
None listed