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
Verified date | June 2009 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 330 |
Est. completion date | July 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 49 Years |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Samsung Medical Center |
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