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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02286076 |
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Date of registration:
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01/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Influence of Laparoscopic Endometrioma Stripping Surgery on Serum Anti-mullerian Hormone Levels
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Scientific title:
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Impact of Laparoscopic Endometrioma Stripping Surgery on Fertility: Pre- Operative and Post- Operative Changes of Serum Anti-mullerian Hormone Levels |
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Date of first enrolment:
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May 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02286076 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Serbia
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Contacts
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Name:
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Svetlana S Spremovic-Radjenovic, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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CCSerbia, School of Medicine, University of Belgrade |
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Name:
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Svetlana S Spremovic- Radjenovic, Professor |
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Address:
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Telephone:
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63696246 |
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Email:
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spremovics@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:Study group: Women with endometrioma(s)
- Age: 18- 42 years of age
- Regular menstrual cycles defined as cycle length between 25- 35 days
- Ultrasound made diagnosis of endometrioma unilateral or bilateral =4 cm in diameter.
- Laparoscopically and histologically confirmed diagnosis.
- Agreement to be enrolled in the study
Control group: Healthy reproductive aged women with tubal, unexplained or male
infertility.
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Exclusion Criteria:
- Previous ovarian surgery
- Suspicious of malignancy
- Known endocrine disorder or other chronic diseases.
- Use of oral contraceptive drug, gonadotropin- releasing hormone (GnRH) agonist/
antagonist, or other drugs related with ovarian function in at least 3 months before
surgery.
Age minimum:
18 Years
Age maximum:
42 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Endometriosis
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Primary Outcome(s)
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Change of antral follicular count (AFC)
[Time Frame: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy]
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Change of estradiol (E2) levels
[Time Frame: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy]
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Change of Inhibin B levels
[Time Frame: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy]
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Change of Anti-mullerian hormone (AMH) levels
[Time Frame: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy]
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Change of follicle-stimulating hormone (FSH)
[Time Frame: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy]
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Secondary Outcome(s)
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Change of CA -125 levels
[Time Frame: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy]
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Change of interleukin-6 (IL-6) levels
[Time Frame: 2nd to 5th day of the cycle in which laparoscopy is performed and 2nd to 5th day of the cycle in 6th month after laparoscopy]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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