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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Samsung Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00928044
First received: June 24, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition
Gynecologic Operations
Anti-Mullerian Hormone
Ovarian Reserve

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Impact of Gynecological Surgery on Ovarian Function in Women of Reproductive Age: Postoperative Changes of Serum Anti-Müllerian Hormone

Further study details as provided by Samsung Medical Center:

Biospecimen Retention:   Samples Without DNA

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)


Estimated Enrollment: 330
Study Start Date: January 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
control groups
They had regular menstrual cycles and no history of pelvic surgery. None had any endocrine disorders (e.g. PCOS) and received any kind of medication that could affect the results within the preceding 6 months, and any woman who had a suspected pathologic lesion in the ovary or menopausal symptoms was excluded.
operation group
1. They had regular menstrual cycles and no history of pelvic surgery. None had any endocrine disorders (e.g. PCOS) and received any kind of medication that could affect the results within the preceding 6 months, and any woman who had a suspected pathologic lesion in the ovary or menopausal symptoms was excluded. 2. Operations were performed for benign ovarian tumors, leiomyoma or adenomyosis

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00928044

Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: DooSeok Choi, MD, PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: DooSeok Choi, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00928044     History of Changes
Other Study ID Numbers: 2008-01-050
Study First Received: June 24, 2009
Last Updated: June 24, 2009
Health Authority: South Korea: Institutional Review Board

ClinicalTrials.gov processed this record on October 01, 2014