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

Phase 4
21 Years
45 Years
Open (Enrolling)
Ovarian Cyst

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Preoperative and postoperative changes in anti-mullerian hormone level

Outcome Description:

The 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.

Outcome Time Frame:

preoperative, postoperative at 1week, 1 and 3 months

Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

March 2013

Related Keywords:

  • Ovarian Cyst
  • Cysts
  • Ovarian Cysts