Assessment of Ovarian Reserve After Laparoscopic Cystectomy Versus Aspiration/Electrocoagulation in the Treatment of Ovarian Endometrioma
1 other identifier
interventional
60
1 country
1
Brief Summary
This is a prospective, multicentric (three centers: 1: Shanghai First Maternity and Infant Hospital, Shanghai, China; 2: International Peace Maternity and Child Health Hospital, Shanghai, China, 3: Shanghai Tongji Hospital, Tongji University School of Medicine, Shanghai ,China), randomized clinical trial that includes patients undergoing laparoscopic surgery for primary unilateral ovarian endometriomas. Eligible patients will be subjected to transvaginal ultrasound before surgery to perform cyst classification (central type, marginal type and outcrop type). Patients are divided to two group: laparoscopic cystectomy group versus laparoscopic aspiration/electrocoagulation group. Biopsy samples in aspiration/electrocoagulation group and excision samples in cystectomy group are all subjected to histopathological examination. Follicular stimulating hormone (FSH), Anti mullerian hormone (AMH) and antral follicular count (AFC) will be measured pre-operative and post-operative. The aim of the study is to determine whether and to what extent the two surgical procedures for ovarian endometrioma, cystectomy and aspiration/electrocoagulation, affect ovarian reserve. The investigators intend to confirm the clinical utility of ultrasonic classification of ovarian endometrioma, FSH, AMH and AFC in the assessment of ovarian reserve, and to promote their use in predicting decreased ovarian reserve. The surgical excision of cystic wall, cystic fluid and peritoneal fluid will be subjected to transmission electron microscope, high resolution mass spectrometry and single-cell RNA sequencing to investigate their cellular and molecular features.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
Typical duration for not_applicable
1 active site
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
October 30, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedJune 11, 2021
June 1, 2021
2.3 years
October 30, 2019
June 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
comparison between the impacts of laparoscopic cystectomy and laparoscopic aspiration /electrocoagulation on ovarian reserve as determined by alteration of AFC estimation in endometrioma patients.
AFC: number of follicles with average diameter of 2-10 mm in both ovaries assessed on day 2-5 of the menstrual cycle.
6 months
Secondary Outcomes (2)
comparison between the impacts of laparoscopic cystectomy and laparoscopic aspiration /electrocoagulation on ovarian reserve as determined by alteration of AMH level in endometrioma patients.
6 months
comparison between the impacts of laparoscopic cystectomy and laparoscopic aspiration /electrocoagulation on ovarian reserve as determined by alteration of FSH level in endometrioma patients.
6 months
Other Outcomes (1)
Ultrasonic classification of ovarian endometrioma
Baseline (before laparoscopy)
Study Arms (2)
aspiration/electrocoagulation
EXPERIMENTALcystectomy
ACTIVE COMPARATORInterventions
laparoscopic aspiration/electrocoagulation of ovarian endometrioma
Eligibility Criteria
You may qualify if:
- Female with age between 18-40 years.
- Regular menstrual cycles
- Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥4cm and ≤6cm.
You may not qualify if:
- Hormone, Gonadotropin-releasing hormone analogues or contraceptive therapy within 6 months before the current surgery and 6 months after surgery.
- Suspected or proven ovarian malignancy.
- Previous ovarian surgery.
- Evidence of polycystic ovary syndrome.
- Evidence of premature ovarian failure or premature menopause.
- Endocrinological diseases affecting ovarian reserve e.g. Diabetes mellitus, hypothyroidism.
- Pregnancy test is positive.
- Lactation.
- Unable or unwilling to give written consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 200000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2019
First Posted
November 5, 2019
Study Start
November 1, 2019
Primary Completion
January 31, 2022
Study Completion
November 30, 2022
Last Updated
June 11, 2021
Record last verified: 2021-06