Assessment of Ovarian Reserve After Laparoscopic Cystectomy Versus Aspiration/Electrocoagulation in the Treatment of Ovarian Endometrioma
Primary Purpose
Ovarian Endometrioma, Ovarian Reserve
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic aspiration/electrocoagulation
laparoscopic cystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Endometrioma
Eligibility Criteria
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.
Sites / Locations
- Shanghai First Maternity and Infant HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
aspiration/electrocoagulation
cystectomy
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT04151173
First Posted
October 30, 2019
Last Updated
June 10, 2021
Sponsor
Shanghai First Maternity and Infant Hospital
Collaborators
International Peace Maternity and Child Health Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04151173
Brief Title
Assessment of Ovarian Reserve After Laparoscopic Cystectomy Versus Aspiration/Electrocoagulation in the Treatment of Ovarian Endometrioma
Official Title
Assessment of Ovarian Reserve After Laparoscopic Cystectomy Versus Aspiration/Electrocoagulation in the Treatment of Ovarian Endometrioma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai First Maternity and Infant Hospital
Collaborators
International Peace Maternity and Child Health Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Endometrioma, Ovarian Reserve
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
aspiration/electrocoagulation
Arm Type
Experimental
Arm Title
cystectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
laparoscopic aspiration/electrocoagulation
Intervention Description
laparoscopic aspiration/electrocoagulation of ovarian endometrioma
Intervention Type
Procedure
Intervention Name(s)
laparoscopic cystectomy
Intervention Description
laparoscopic cystectomy of ovarian endometrioma
Primary Outcome Measure Information:
Title
comparison between the impacts of laparoscopic cystectomy and laparoscopic aspiration /electrocoagulation on ovarian reserve as determined by alteration of AFC estimation in endometrioma patients.
Description
AFC: number of follicles with average diameter of 2-10 mm in both ovaries assessed on day 2-5 of the menstrual cycle.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
comparison between the impacts of laparoscopic cystectomy and laparoscopic aspiration /electrocoagulation on ovarian reserve as determined by alteration of AMH level in endometrioma patients.
Description
AMH is assessed on venous blood samples
Time Frame
6 months
Title
comparison between the impacts of laparoscopic cystectomy and laparoscopic aspiration /electrocoagulation on ovarian reserve as determined by alteration of FSH level in endometrioma patients.
Description
FSH is assessed on venous blood samples obtained on day 2-5 of the menstrual cycle
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Ultrasonic classification of ovarian endometrioma
Description
preoperative transvaginal ultrasonic classification of ovarian endometrioma (central type, marginal type and outcrop type)
Time Frame
Baseline (before laparoscopy)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Sun
Phone
86-021-20261258
Email
sunjing61867@126.com
Facility Information:
Facility Name
Shanghai First Maternity and Infant Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jing Sun
Phone
86-021-20261258
Email
sunjing61867@126.com
First Name & Middle Initial & Last Name & Degree
Weilin Tan
12. IPD Sharing Statement
Learn more about this trial
Assessment of Ovarian Reserve After Laparoscopic Cystectomy Versus Aspiration/Electrocoagulation in the Treatment of Ovarian Endometrioma
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