Ovarian Cyst BenignNCT06350227
Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst
A study testing the absorbable hemostat and suture, electrocoagulation and suture and suture in people with Ovarian Cyst Benign, run by West China Second University Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Cyst Benign
- What is being tested?
- the absorbable hemostat and suture, electrocoagulation and suture and suture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with benign ovarian cysts requiring surgical management.
- Women who choose laparoscopic ovarian cystectomy voluntarily sign a surgical consent form.
- Women participating in this study recognize three hemostatic methods and are ready to randomly accept one of them.
- Women aged between 18 and 40 years old.
- 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.
- Women with no previous history of ovarian surgery, chemotherapy, or pelvic radiation therapy.
- 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.
Who cannot join
- Polycystic ovary syndrome.
- Pregnancy or lactation period.
- Women with active pelvic inflammatory disease, genital or extragenital malignant tumors.
- Women who have undergone two or more pelvic or abdominal surgeries.
- Evidence of premature ovarian failure or premature menopause, such as AMH<1ng/ml.
- Conversion to open surgery.
- Women who refuse to sign informed consent or are unable to attend follow-up regularly.
- Cysts that do not originate from the ovaries or have the characteristics of malignant tumors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Second University Hospital, Sichuan University
Chengdu, Sichuan
Yanru Long, 86-13550169017, 2801443341@qq.com
About this study
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.
- Conditions
- Ovarian Cyst Benign
- Being tested
- the absorbable hemostat and suture, electrocoagulation and suture, suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the absorbable hemostat and sutureCombination product
The hemostasis method of the experimental group is to use both the absorbable hemostat and suture.
electrocoagulation and sutureCombination product
The active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding.
sutureOther
The placebo comparator is to use suture alone for hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| The absorbable hemostat | Experimental | Not described Receives: Combination Product: the absorbable hemostat and suture |
| Electrocoagulation | Active comparator | Not described Receives: Combination Product: electrocoagulation and suture |
| Suture alone | Placebo comparator | Not described Receives: Other: suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative quantity and postoperative quantity for 1, 3, and 6 months
Secondary outcomes (1)
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.
Measured: Preoperative level and postoperative level at 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start10 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Cyst BenignStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanru Long, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350227
- Sponsor's protocol ID
- WestChinaSU
- Status last verified
- May 2024
- First submitted
- 1 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst
- ClinicalTrials.gov ID
- NCT06350227
- Acronym / sponsor ID
- WestChinaSU
- Conditions
- Ovarian Cyst Benign
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The absorbable hemostat | Experimental | Combination Product: the absorbable hemostat and suture |
| Electrocoagulation | Active comparator | Combination Product: electrocoagulation and suture |
| Suture alone | Placebo comparator | Other: suture |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women diagnosed with benign ovarian cysts requiring surgical management.
- Women who choose laparoscopic ovarian cystectomy voluntarily sign a surgical consent form.
- Women participating in this study recognize three hemostatic methods and are ready to randomly accept one of them.
- Women aged between 18 and 40 years old.
- 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.
Key exclusion criteria (8 listed)
- Polycystic ovary syndrome.
- Pregnancy or lactation period.
- Women with active pelvic inflammatory disease, genital or extragenital malignant tumors.
- Women who have undergone two or more pelvic or abdominal surgeries.
- Evidence of premature ovarian failure or premature menopause, such as AMH<1ng/ml.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the absorbable hemostat and sutureThe hemostasis method of the experimental group is to use both the absorbable hemostat and suture. | Combination product | The absorbable hemostat |
| electrocoagulation and sutureThe active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding. | Combination product | Electrocoagulation |
| sutureThe placebo comparator is to use suture alone for hemostasis. | Other | Suture alone |
Primary outcome
Antral Follicle Count (AFC)
Time frame: Preoperative quantity and postoperative quantity for 1, 3, and 6 months
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.
1 secondary outcome
Anti-Mullerian hormone (AMH)
Time frame: Preoperative level and postoperative level at 1, 3, and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the absorbable hemostat and suture, electrocoagulation and suture and suture in people with Ovarian Cyst Benign, run by West China Second University Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanru Long (86-13550169017, 2801443341@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antral Follicle Count (AFC) (time frame: Preoperative quantity and postoperative quantity for 1, 3, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.