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The Impact of Gynecological Surgery on Ovarian Function in Women of Reproductive Age: Postoperative Changes of Serum Anti-Müllerian Hormone


N/A
20 Years
49 Years
Open (Enrolling)
Female
Gynecologic Operations, Anti-Mullerian Hormone, Ovarian Reserve

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Trial Information

The Impact of Gynecological Surgery on Ovarian Function in Women of Reproductive Age: Postoperative Changes of Serum Anti-Müllerian Hormone


Premenopausal women were enrolled and were allocated into two groups; operation and control
group. Operations were performed for benign ovarian tumors, leiomyoma or adenomyosis. All
eligible women were identified from the Samsung Medical Center. Written informed consent was
obtained from all subjects and the study was approved by the Institutional Review Board of
Samsung Medical Center.

A complete medical history was taken, and physical and gynecological examinations were
performed at baseline. Data included information on age, menstrual cycle, parity, weight,
height, and BMI. The follow-up length was 3 months. Blood sample was taken before and in 1
week, 1 month and 3 months after surgery for operation group or at the time of screening for
control group, and transvaginal ultrasonography was performed with AMH sampling.

After collection of blood, serum was stored at -70ºC until the measurement of AMH level.
Serum levels of AMH were determined by an enzyme-linked immunosorbent assay using commercial
kit (Beckman Coulter Inc., Paris, France). The detection limit of the assay was 0.14 ng/mL,
and the intra- and inter-assay coefficients of variation were 12.3% and 14.2%, respectively.

Ultrasonographic examination was performed using the ALOKA prosound SSD-3500 (ALOKA,
Wallingford, CT, USA) with a 7.5-MHz vaginal probe for color Doppler ultrasonography to
assess the ovarian artery flow at the ovarian hilum. The pulsatile index (PI) and resistance
index (RI) values were calculated according to the formula PI=[S-D]/mean and RI=[S-D]/S,
where S was the peak systolic flow velocity; D was diastolic velocity; and the mean was the
mean flow velocity. All examinations were conducted by the same investigator to minimize
interobserver bias, and parameters were measured at least 3 times and the mean value was
recorded.

Operations were performed by gynecologists in our center using the technique of
laparoscopy-assisted vaginal or trans-abdominal approaches for hysterectomy and using
oophorectomy or cystectomy method for ovarian disease.

Statistical analyses were performed using Statistical Analysis System (SAS Institute Inc.,
version 9.1, Enterprise Guide 3.0, Cary, NC, USA) and R (version 2.7.2) by a statistician in
our hospital. The Fisher's exact test was used for frequency data. The variables presenting
normal distribution were compared by t test or analysis of variance. For the variables which
did not show normal distribution, the Kruskal-Wallis test or Wilcoxon test were used. A
P-value <0.05 was considered statistically significant.


Inclusion Criteria:



- For both operation and control groups, women were eligible for inclusion if they had
regular menstrual cycles and no history of pelvic surgery.

Exclusion Criteria:

- No endocrine disorders (e.g. PCOS).

- Received any kind of medication that could affect the results within the preceding 6
months.

- Any woman who had a suspected pathologic lesion in the ovary or menopausal symptoms.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

DooSeok Choi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

South Korea: Institutional Review Board

Study ID:

2008-01-050

NCT ID:

NCT00928044

Start Date:

January 2008

Completion Date:

July 2009

Related Keywords:

  • Gynecologic Operations
  • Anti-Mullerian Hormone
  • Ovarian Reserve

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