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

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.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Reserve; Ovarian Endometrioma
• Intervention / Treatment: Procedure: laparoscopic aspiration/electrocoagulation; Procedure: laparoscopic cystectomy

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jing Sun; Phone Number: 86-021-20261258; Email: sunjing61867@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai first maternity and infant hospital
      • Contact: jing Sun; Phone Number: 86-021-20261258; Email: sunjing61867@126.com
      • Sub-Investigator: Weilin Tan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: aspiration/electrocoagulation	Procedure: laparoscopic aspiration/electrocoagulation; laparoscopic aspiration/electrocoagulation of ovarian endometrioma
ACTIVE_COMPARATOR: cystectomy	Procedure: laparoscopic cystectomy; laparoscopic cystectomy of ovarian endometrioma

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasonic classification of ovarian endometrioma	preoperative transvaginal ultrasonic classification of ovarian endometrioma (central type, marginal type and outcrop type)	Baseline (before laparoscopy)

Collaborators and Investigators

• Sponsor: Shanghai First Maternity and Infant Hospital
• Collaborators: Shanghai Tongji Hospital, Tongji University School of Medicine; International Peace Maternity and Child Health Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ANTICIPATED): January 31, 2022
• Study Completion (ANTICIPATED): November 30, 2022

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (ACTUAL): November 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: ShanghaiFMIH Jing Sun

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No