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Anti-Mullerian Hormone Changes After Laparoscopic Ovarian Cystectomy for Endometrioma Compared With the Non-ovarian Conditions

Sponsor
Thammasat University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01919333
Collaborator
(none)
56
Enrollment
1
Location

Study Details

Study Description

Brief Summary

This aim of the study is to evaluate the impact of endometrioma and laparoscopic cystectomy on ovarian reserve as measured by serum antimullerian hormone and to study the different effects of levels of serum antimullerian hormone between laparoscopic cystectomy and the non-ovarian pelvic surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    56 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Dec 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    laparoscopic ovarian cystectomy

    the group who laparoscopic ovarian cystectomy are performed for endometrioma
    laparoscopic non- ovarian pelvic surgery

    the group whom laparoscopic non- ovarian pelvic surgery are performed

    Outcome Measures

    Primary Outcome Measures

    1. Serum AMH levels [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • • Participants must be between the ages of 18 - 45 during enter the study .

    • Every participants have to completely understand the process of this study and have written informed consent .

    • Having regular menstrual cycles (21-35 days) at the time of operation

    • no evidence of any other endocrine disorders such as diabetes mellitus, thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, or adrenal insufficiency.

    • undergo laparoscopic ovarian cystectomy or laparoscopic non- ovarian pelvic surgery for benign pelvic disease

    • No previous history of adnexal surgery

    • No any suspicious findings of malignant ovarian diseases

    • Never taking any medication such as oral pill and hormonal drugs within 3 months before the enrollment.

    • pathological diagnosis of excised ovarian tissue confirm as endometriotic cyst in study group and other benign pelvic disease in control group

    Exclusion Criteria:

    • polycystic ovarian syndrome according to the Rotterdam criteria

    • pathological report as the malignant diseases

    • have operation conversion to open-laparotomy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of medicine , Thammasat university Rangsit Pathumthanee Thailand 12120

    Sponsors and Collaborators

    • Thammasat University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chamnan Tanprasertkul, Associate Professor, Thammasat University
    ClinicalTrials.gov Identifier:
    NCT01919333
    Other Study ID Numbers:
    • MTU-OB-3-096/56
    First Posted:
    Aug 9, 2013
    Last Update Posted:
    Aug 9, 2013
    Last Verified:
    Aug 1, 2013

    Study Results

    No Results Posted as of Aug 9, 2013