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

Ovarian Reserve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04151173
• Other study ID #: ShanghaiFMIH Jing Sun
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: June 2021
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Jing Sun
• Phone: 86-021-20261258
• Email: sunjing61867[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Ovarian Endometrioma
• Ovarian Reserve

Intervention

Procedure:
• laparoscopic aspiration/electrocoagulation
laparoscopic aspiration/electrocoagulation of ovarian endometrioma
• laparoscopic cystectomy
laparoscopic cystectomy of ovarian endometrioma

Locations

Country	Name	City	State
China	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital	International Peace Maternity and Child Health Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ultrasonic classification of ovarian endometrioma	preoperative transvaginal ultrasonic classification of ovarian endometrioma (central type, marginal type and outcrop type)	Baseline (before laparoscopy)
Primary	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	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
Secondary	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