Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05858307 |
| Other study ID # |
2022.228 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 22, 2022 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
May 2023 |
| Source |
Chinese University of Hong Kong |
| Contact |
WING IU LI |
| Phone |
+852 35051764 |
| Email |
wingiuli[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study aims to assess the association of Anti-Müllerian hormone (AMH) with polycystic
ovarian syndrome, premature ovarian insufficiency and fertility. The main objectives include
the following:
1. To study the level of serum AMH in women with PCOS and to evaluate the utility of serum
AMH in the diagnosis of PCOS.
2. To evaluate the level of serum AMH in women with POI and to evaluate the utility of
serum AMH in the management of POI.
3. To evaluate the associations of basal AMH level with FSH level and AFC respectively for
women undergoing ART treatment.
4. To determine the optimal regimen of gonadotropin for ovarian stimulation for women
undergoing ART treatment.
5. To evaluate the predictive value of serum AMH in reproductive outcomes including oocyte
quality, embryo quality, pregnancy loss, clinical pregnancy and live birth rate in women
undergoing ART treatment.
Description:
[Background] Anti-Müllerian hormone (AMH), which level can be assessed in serum, is a product
of follicular granulosa cells of preantral and small antral follicles in the ovary. AMH
expression increases prior to follicle-stimulating hormone (FSH)-dependent selection
(follicles up to 8 mm) and rapidly decreases thereafter (follicles > 8 mm. Thus, serum AMH
level is a reliable marker of functional ovarian reserve as it reflects the pool of growing
follicles. Since AMH is relatively cycle independent and has no inter-rater variability, it
is considered to be a more reliable biomarker of ovarian function across an array of clinical
conditions when compared with follicle-stimulating hormone (FSH) and antral follicular count
(AFC).
PCOS is a common endocrine
disorder that causes menstrual irregularity and hyperandrogenism in women. It affects
approximately 4-20% of women of reproductive age. Women with PCOS have been shown to have
elevated AMH levels when compared with women without PCOS as there is an increased number of
ovarian follicles in PCOS. Therefore, AMH is being increasingly recognised as a marker for
the diagnosis of PCOS. However, a specific cutoff value is yet to be determined. When the
issue is addressed, serum AMH levels could potentially replace ultrasound in the diagnosis of
PCOS as ultrasound is more costly and less accessible.
POI is defined as the
cessation of ovarian function before the age of 40 years. Timely diagnosis is important in
order to appropriately counsel and treat the patients with POI.
Prompt initiation of hormone replacement therapy is vital to minimise the risk of long-term
health complications including osteoporosis and premature cardiovascular disease. AMH levels
were significantly low to undetectable in women with POI. Since AMH is independent of the
timing in a menstrual cycle, the measurement may be beneficial in the phase of menstrual
irregularity and could potentially help to assess the progression of ovarian senescence.
Serum AMH level is an important indicator of women's
ovarian reserve and a crucial tool in assisted reproductive technology (ART) for the
evaluation of women's fertility. A recent systematic review concluded that basal serum AMH is
a strong pretreatment predictor of poor response to controlled ovarian stimulation (COS) and
correlates with the risk of ovarian hyperstimulation syndrome. As such, clinicians can
individualise the stimulation protocols to optimise the ovarian response. In addition,
AMH-based prognostication counselling can be provided to patients with realistic expectation
regarding the ART outcomes.
Ovarian reserve has a well-established positive correlation with pregnancy outcome. However,
current evidence of AMH in the prediction of reproductive outcome following ART treatment
remains controversial. Therefore, there is a need to study the predictive value of AMH on
pregnancy outcome in women undergoing ART.
[Hypothesis]
1. Serum AMH level is elevated in women with PCOS.
2. Serum AMH level is very low or undetectable in women with POI.
3. Serum AMH level has a significant correlation with FSH and AFC in women undergoing ART
treatment.
4. Serum AMH level can predict reproductive outcomes following ART treatment.
[Study design] This is a prospective observational study.
[Methods] Investigators will collect data from patients who undergo management for PCOS and
POI in the Department of Obstetrics and Gynaecology at the Prince of Wales Hospital from 2022
to 2026. For patients undergoing investigation of PCOS and POI, routine venous blood tests
for AMH and hormonal profile including FSH, luteinizing hormonal (LH), oestradiol (E2) levels
will be obtained. For patients undergoing ART treatment, routine venous blood tests for AMH
and hormonal profile, and transvaginal ultrasound for AFC will be arranged to assess the
patients' ovarian reserve prior to the commencement of treatment. Patients will be recruited
and consent will be obtained for the storage of any remaining serum from the blood tests. The
stored blood samples will then be retrieved for this study.
[Data processing and analysis] Data analysis will be performed using the Statistical Packages
of Social Sciences for Windows (SPSS, Inc). Data will be presented by percentage, mean and
standard deviation, and median where appropriate. Comparisons between groups will be carried
out by Student T test/Mann-Whitney U test for continuous variables and Chi-square/Fisher's
exact test for categorical data. Two-tailed P<0.05 will be considered significant.
[Sample size] All patients fulfilling the inclusion criteria attending the Department of
Obstetrics and Gynaecology at the Prince of Wales Hospital from 2022 to 2026 will be
recruited. The sociodemographic records of the participants including their menstrual
history, routine hormonal results, ovarian reserve assessment and ultrasound assessment of
AFC will be obtained. Metabolic screening results and ART treatment records and subsequent
laboratory and reproductive outcome will be obtained if necessary.
