Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst

Ovarian Cyst Benign Clinical Trial

Official title:

Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06350227
• Other study ID #: WestChinaSU
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: West China Second University Hospital
• Contact: Yanru Long
• Phone: 86-13550169017
• Email: 2801443341[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Women diagnosed with benign ovarian cysts requiring surgical management.

2. Women who choose laparoscopic ovarian cystectomy voluntarily sign a surgical consent form.

3. Women participating in this study recognize three hemostatic methods and are ready to randomly accept one of them.

4. Women aged between 18 and 40 years old.

5. It was diagnosed by ultrasound as unilateral or bilateral benign ovarian cysts with a maximum diameter of 4-8cm. The nature of the cysts is ultimately confirmed by postoperative pathological examination.

6. Women with no previous history of ovarian surgery, chemotherapy, or pelvic radiation therapy.

7. Patients with no history of endocrine disorders such as hyperprolactinemia, hypothyroidism, or hyperthyroidism, and no history of endocrine therapy within 6 months before laparoscopic ovarian cystectomy.

Exclusion Criteria:

1. Polycystic ovary syndrome.

2. Pregnancy or lactation period.

3. Women with active pelvic inflammatory disease, genital or extragenital malignant tumors.

4. Women who have undergone two or more pelvic or abdominal surgeries.

5. Evidence of premature ovarian failure or premature menopause, such as AMH<1ng/ml.

6. Conversion to open surgery.

7. Women who refuse to sign informed consent or are unable to attend follow-up regularly.

8. Cysts that do not originate from the ovaries or have the characteristics of malignant tumors.

Related Conditions & MeSH terms

• Cysts
• Ovarian Cyst Benign
• Ovarian Cysts

Intervention

Combination Product:
• the absorbable hemostat and suture
The hemostasis method of the experimental group is to use both the absorbable hemostat and suture.
• electrocoagulation and suture
The active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding.

Other:
• suture
The placebo comparator is to use suture alone for hemostasis.

Locations

Country	Name	City	State
China	West China Second University Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Second University Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antral Follicle Count (AFC)	Antral follicle count (AFC) generally refers to the basic follicles in ovaries, which have not yet begun to develop. If the number of AFC is within the normal range (usually 5-10), it indicates that the ovarian reserve function is normal. If the number is low, it generally means that the ovarian reserve function is relatively low. If the number is high, it may be caused by polycystic ovary syndrome. Besides, AFC can be detected through ultrasound examination, and the number of AFC can directly reflect the ovarian reserve of each ovary.	Preoperative quantity and postoperative quantity for 1, 3, and 6 months
Secondary	Anti-Mullerian hormone (AMH)	Anti-Mullerian hormone (AMH), which can be detected through blood tests, is considered a reliable marker produced by ovarian granulosa cells. The level of AMH indirectly reflects the number of ovarian follicular pools and the joint reserve of both ovaries. In addition, the level of AMH fluctuates less throughout the menstrual cycle. Besides, AMH is almost unrelated to the menstrual cycle and is not affected by gonadotropin-releasing hormone (GnRH) agonists or oral contraceptives.	Preoperative level and postoperative level at 1, 3, and 6 months