Gynecologic OperationsNCT00928044
The Impact of Gynecological Surgery on Ovarian Function in Women of Reproductive Age: Postoperative Changes of Serum Anti-Müllerian Hormone (AMH)
An observational study of Gynecologic Operations and Anti-Mullerian Hormone, run by Samsung Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Operations, Anti-Mullerian Hormone, Ovarian Reserve
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- For both operation and control groups, women were eligible for inclusion if they had regular menstrual cycles and no history of pelvic surgery.
Who cannot join
- 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.
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJan 2008
- Primary completionJan 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic OperationsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- DooSeok Choi, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928044
- Sponsor's protocol ID
- 2008-01-050
- Status last verified
- Jun 2009
- First submitted
- 24 Jun 2009
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Gynecological Surgery on Ovarian Function in Women of Reproductive Age: Postoperative Changes of Serum Anti-Müllerian Hormone
- ClinicalTrials.gov ID
- NCT00928044
- Acronym / sponsor ID
- 2008-01-050
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- For both operation and control groups, women were eligible for inclusion if they had regular menstrual cycles and no history of pelvic surgery.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DooSeok Choi, MD, PhD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Operations and Anti-Mullerian Hormone, run by Samsung Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2009.