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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01919333
Other study ID # MTU-OB-3-096/56
Secondary ID
Status Unknown status
Phase Phase 3
First received August 6, 2013
Last updated August 6, 2013
Start date December 2012

Study information

Verified date August 2013
Source Thammasat University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Unknown status
Enrollment 56
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Faculty of medicine , Thammasat university Rangsit Pathumthanee

Sponsors (1)

Lead Sponsor Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum AMH levels 6 months
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