Ovarian Reserve Clinical Trial
Official title:
The Impact of Gynecological Surgery on Ovarian Function in Women of Reproductive Age: Postoperative Changes of Serum Anti-Müllerian Hormone
Besides the removal of lesions, the purpose of surgeries has been extended to the
improvement of quality of life after procedures. Minimally invasive surgeries enabled women
to experience less pain, less hospital days. It is important to maintain the ovarian
function because ovarian hormones have protective effects about bone and cardiovascular
diseases. Until now many operation techniques for preserving ovarian function were used in
gynecological field, however, how much these methods affect on ovarian function is seldom
known. For the evaluation of remained ovarian function, ultrasound examination is useful
method. However, it might take several months till one can determine ovarian function and
could not exactly evaluate ovarian reserve. Until now, there have been controversies
regarding ovarian function after gynecological surgeries. These inconsistent results might
derive from the methods for assessing ovarian function because serum gonadotropins and sex
steroids levels vary according to the menstrual cycle.
In this aspect, anti-Müllerian hormone (AMH) has recently been advocated as a good marker
for ovarian reserve. AMH is one of the TGF-beta superfamily and induces the regression of
Müllerian duct. Studies with AMH showed no significant variation throughout the menstrual
cycle and cycle-to-cycle consistency, therefore, it will provide more reliable data on the
changes of ovarian reserve after operations.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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