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Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Endometriosis

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03020108
Collaborator
(none)
90
Enrollment
1
Location
12
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study population will comprise of 90 women age varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility. The blood samples will be drawn for analysis of serum biomarkers.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood sample

Detailed Description

The participants will be accepted for the study between 1st of August 2016 to 30th June 2017. 2 cc blood samples will be drawn from the antecubital vein for serum analysis of caspase 3, annexin a2 and soluble fas levels before the operations. The patients will divide into three groups. The group 1 will comprise of 30 patients with benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination. The group 2 will comprise of 30 patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. The group 3 will comprise of 30 patients with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. The blood samples will be kept in -80 C degree after centrifuge till at the end of the study.The relation between serum caspase 3, annexin a2 and soluble fas levels and severity of endometriosis will be analysed.

Study Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Relation Between Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Severity of Endometriosis
Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Group 1

The group 1 will comprise of 30 patients with benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination.

Other: Blood sample
2 cc blood samples will be drawn from antecubital vein
Other Names:
  • Serum caspase 3, annexin a2 and soluble fas levels

    		•
    Group 2

    The group 2 will comprise of 30 patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American Society for Reproductive Medicine classification.

    Other: Blood sample
    2 cc blood samples will be drawn from antecubital vein
    Other Names:
  • Serum caspase 3, annexin a2 and soluble fas levels

    		•
    Group 3

    The group 3 will comprise of 30 patients with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for Reproductive Medicine classification.

    Other: Blood sample
    2 cc blood samples will be drawn from antecubital vein
    Other Names:
  • Serum caspase 3, annexin a2 and soluble fas levels

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determine endometriosis severity with serum markers [1 year]

    Secondary Outcome Measures

    1. To determine rectal involvement with serum markers [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • The women ages varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of >4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility.
    Exclusion Criteria:
    • The women with malignant diseases, chronic bowel disease, other defined cause of infertility.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology Istanbul Turkey 34250

    Sponsors and Collaborators

    • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    Investigators

    • Principal Investigator: Cihan Kaya, M.D., Bakırkoy Dr. Sadi Konuk Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Bakirkoy Dr. Sadi Konuk Research and Training Hospital
    ClinicalTrials.gov Identifier:
    NCT03020108
    Other Study ID Numbers:
    • 2016/190
    First Posted:
    Jan 13, 2017
    Last Update Posted:
    Aug 28, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Endometriosis

    Study Results

    No Results Posted as of Aug 28, 2017