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

Not Applicable

• Conditions: Ovarian Endometrioma; Ovarian Reserve
• Interventions: Procedure: laparoscopic cystectomy; Procedure: laparoscopic aspiration/electrocoagulation

• Registration Number: NCT04151173
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-30
• Study Start: 2019-11-01
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-11
• Primary Completion: 2022-01-31
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Female with age between 18-40 years.
• Regular menstrual cycles
• Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥4cm and ≤6cm.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cystectomy	laparoscopic cystectomy	-
aspiration/electrocoagulation	laparoscopic aspiration/electrocoagulation	-

Primary Outcome Measures

Name	Time	Method
comparison between the impacts of laparoscopic cystectomy and laparoscopic aspiration /electrocoagulation on ovarian reserve as determined by alteration of AFC estimation in endometrioma patients.	6 months	AFC: number of follicles with average diameter of 2-10 mm in both ovaries assessed on day 2-5 of the menstrual cycle.

Secondary Outcome Measures

Name	Time	Method
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	AMH is assessed on venous blood samples
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	FSH is assessed on venous blood samples obtained on day 2-5 of the menstrual cycle

Trial Locations

Locations (1)

Shanghai First Maternity and Infant Hospital; 🇨🇳 Shanghai, Shanghai, China