Assessment of Ovarian Reserve After Laparoscopic Cystectomy Versus Aspiration/Electrocoagulation in the Treatment of Ovarian Endometrioma

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Ovarian Reserve After Laparoscopic Cystectomy Versus Aspiration/Electrocoagulation in the Treatment of Ovarian Endometrioma

Conditions
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Ovarian Endometrioma, Ovarian Reserve

Intervention / Treatment
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* Procedure: laparoscopic aspiration/electrocoagulation
* Procedure: laparoscopic cystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female with age between 18-40 years. Regular menstrual cycles Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥4cm and ≤6cm. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aspiration/electrocoagulation<br> | Procedure: laparoscopic aspiration/electrocoagulation<br>* laparoscopic aspiration/electrocoagulation of ovarian endometrioma<br>|
| Active Comparator: cystectomy<br> | Procedure: laparoscopic cystectomy<br>* laparoscopic cystectomy of ovarian endometrioma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison between the impacts of laparoscopic cystectomy and laparoscopic aspiration /electrocoagulation on ovarian reserve as determined by alteration of AMH level in endometrioma patients. | AMH is assessed on venous blood samples | 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. | FSH is assessed on venous blood samples obtained on day 2-5 of the menstrual cycle | 6 months |