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

NCT ID: NCT04151173

Last Updated: 2021-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-11-30

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.

Detailed Description

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Conditions

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Ovarian Endometrioma Ovarian Reserve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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aspiration/electrocoagulation

Group Type EXPERIMENTAL

laparoscopic aspiration/electrocoagulation

Intervention Type PROCEDURE

laparoscopic aspiration/electrocoagulation of ovarian endometrioma

cystectomy

Group Type ACTIVE_COMPARATOR

laparoscopic cystectomy

Intervention Type PROCEDURE

laparoscopic cystectomy of ovarian endometrioma

Interventions

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laparoscopic aspiration/electrocoagulation

laparoscopic aspiration/electrocoagulation of ovarian endometrioma

Intervention Type PROCEDURE

laparoscopic cystectomy

laparoscopic cystectomy of ovarian endometrioma

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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International Peace Maternity and Child Health Hospital

OTHER

Sponsor Role collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role collaborator

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Sun

Role: CONTACT

86-021-20261258

Facility Contacts

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jing Sun

Role: primary

86-021-20261258

Other Identifiers

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ShanghaiFMIH Jing Sun

Identifier Type: -

Identifier Source: org_study_id

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