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The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation

The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01631253
Enrollment
90
Registered
2012-06-29
Start date
2011-10-31
Completion date
2013-03-31
Last updated
2012-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cyst

Brief summary

The purpose of this study is to investigate the impact on ovarian reserve after single- port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change.

Detailed description

With the recent development of surgical instruments techniques, minimally invasive surgery is more feasible in various field of surgery. Laparoscopic surgery has potential benefit of decreased patient discomfort, short hospital stay, superior cosmetic results and decreased convalescence time. Recently, various efforts have been continued for minimally invasive surgery, one of the recently emerging concepts is single port surgery. Several studies have demonstrated that single-port laparoscopic surgery is feasible and safe in gynecology. However, some limits could be occurred, such as the occurrence of less freedom degrees between the instruments and limits surgical vision, thus limiting surgeon's movements. So, two-port laparoscopy combined access through umbilical and additional suprapubic incision have been used and reported. In case of single port access laparoscopic ovarian cyst enucleation, due to limits of surgeon's movements, cyst enucleation or bipolar electrocoagulation of the ovarian parenchyma adversely affected ovarian function. Some studies reported that after laparoscopic cyst enucleation, there had been shown marked reduction of ovarian function compared with surgery by laparotomy. Therefore we attempt to investigate the impact of single port laparoscopy that have limits of surgical procedures on ovarian reserve after ovarian cyst enucleation. To evaluate ovarian reserve change, we will use the anti-mullerian hormone. It is produced by granulosa cells of preantral and small antral follicles and has been recently acknowledged as the useful, reliable, and sensitive hormonal serum marker of the ovarian primordial follicle pool. In addition, the AMH level represents a stronger independent marker of ovarian reserve without significant fluctuation during the menstrual cycle, which progressively decreases with age. Therefore, this prospective study is performed to compare the differences in ovarian reserve after single-port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change. Serum anti mullerian hormone is measured at preoperative and at postoperative 1week, 1 and 3 months.

Interventions

PROCEDURELaparoscopic ovarian cyst enucleation

Sponsors

CHA University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Age: 21-45 years Ultrasound * CT, MRI diagnosis as ovarian cyst , need to cyst enucleation * Size of cyst : between 3cm and 10cm * Regular menstrual cycles defined as cycle length between 25 and 35 days * Agreement to be enrolled in the study.

Exclusion criteria

* Previous ovarian surgery * suspicious of malignancy * Postmenopause * Use of oral contraceptive drug, GnRH agonist /antagonist, or other drugs related with ovarian function in last 3 months * Known endocrine disorder

Design outcomes

Primary

MeasureTime frameDescription
Preoperative and postoperative changes in anti-mullerian hormone levelpreoperative, postoperative at 1week, 1 and 3 monthsThe primary outcome of our study is the impact on ovarian reserve determined by AMH after the application of the three laparoscopic techniques for the treatment of ovarian cyst.In all study patients, at preoperation and 1 week, 1 month, 3 month after operation, AMH is serially measured.

Secondary

MeasureTime frame
postoperative pain scores

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026