Association Between Laparoscopic Removal of Endometriomas and Anti-mullerian Hormone Levels
Effects of Laparoscopic Endometrioma Removal on Anti-mullerian Hormone Levels
1 other identifier
observational
102
0 countries
N/A
Brief Summary
Laparoscopic excision of endometriotic cysts is the main stream surgical intervention for treatment of endometriosis. However there is evidence that intervention may effect ovarian reserve by destruction of healthy ovarian tissue during surgery. Available evidence on the topic are contradictory and employed research methodology are diverse. There is need for an adequately powered research with proper methodology to assess actual effects of surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2016
Typical duration for all trials
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
First Submitted
Initial submission to the registry
February 15, 2016
CompletedFirst Posted
Study publicly available on registry
February 19, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 19, 2016
February 1, 2016
2.4 years
February 15, 2016
February 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-Mullerian hormone levels
AMH (anti-mullerian hormone) levels will be measured before surgery and during various time points up to 1 year after the surgery
1 year
Study Arms (1)
Laparoscopic removal
Patients with endometrioma who will undergo laparoscopic removal of cysts.
Interventions
Women with endometrioma lesions will undergo laparoscopic removal. Cysts will be enucleated with blunt dissection of the cyst capsule and following traction, counter traction maneuver. Bipolar coagulation will be used sparsely and suturing will be the predominant choice for achieving bleeding control.
Eligibility Criteria
This study will recruit healthy women besides having endometrioma cysts who will undergo laparoscopic removal of such lesions.
You may qualify if:
- Women with endometrioma cyst(s)
- Women of age under 35 years old
- Women without any previous ovarian surgery
You may not qualify if:
- Combined oral contraceptive or long term GnRH (gonadotropin-releasing hormone) analog use in the preceding 3 months to enrolment
- Having another cystic lesion besides endometrioma
- Need for extensive bipolar coagulation during surgery
- Any anatomical problem preventing evaluation of ovaries with high-resolution ultrasound
- Postoperative pathology excluding endometrioma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Blood serum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erkan Kalafat
Ankara University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
February 15, 2016
First Posted
February 19, 2016
Study Start
April 1, 2016
Primary Completion
September 1, 2018
Study Completion
December 1, 2018
Last Updated
February 19, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will share