NCT01919333

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

August 6, 2013

Last Update Submit

August 6, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Serum AMH levels

    6 months

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Reproductive women , age 18- 45 years who undergo laparoscopic ovarian cystectomy or laparoscopic non- ovarian pelvic surgery

You may qualify if:

  • 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

You may not qualify if:

  • polycystic ovarian syndrome according to the Rotterdam criteria
  • pathological report as the malignant diseases
  • have operation conversion to open-laparotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine , Thammasat university

Rangsit City Municipality, Pathumthanee, 12120, Thailand

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2013

First Posted

August 9, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations