An interventional study of the absorbable hemostat and suture and electrocoagulation and suture in Ovarian Cyst Benign, sponsored by West China Second University Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by West China Second University Hospital · Not applicable, Interventional, and Treatment
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.
80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.
This study's planned enrollment of 165 is above the median of 74 across 51 interventional studies indexed under Ovarian Cysts.
Browse Ovarian Cysts studies →West China Second University Hospital is the lead sponsor of 38 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: the absorbable hemostat and suture
Combination Product: electrocoagulation and suture
Other: suture
The hemostasis method of the experimental group is to use both the absorbable hemostat and suture.
The active comparator group is to use electrocoagulation and suture simultaneously to stop bleeding.
The placebo comparator is to use suture alone for hemostasis.
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.
Time frame: Preoperative quantity and postoperative quantity for 1, 3, and 6 months
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.
Time frame: Preoperative level and postoperative level at 1, 3, and 6 months
Started Apr 2024 (actual). Primary completion is estimated for Dec 2025, 20 months after the start.
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West China Second University Hospital