Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05858307
Status:
RECRUITING
Last Update Posted:
2023-05-15
First Post:
2023-02-06
Brief Title:
Clinical Application of Serum Anti-Müllerian Hormone AMH Measurements
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Clinical Application of Serum Anti-Müllerian Hormone AMH Measurements
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
Association between AMH and polycystic ovarian syndrome PCOS 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
Association between AMH and premature ovarian insufficiency POI 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
Associations between AMH and Fertility Serum AMH level is an important indicator of womens ovarian reserve and a crucial tool in assisted reproductive technology ART for the evaluation of womens 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 testMann-Whitney U test for continuous variables and Chi-squareFishers exact test for categorical data Two-tailed P005 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
Association between AMH and polycystic ovarian syndrome PCOS 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
Association between AMH and premature ovarian insufficiency POI 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
Associations between AMH and Fertility Serum AMH level is an important indicator of womens ovarian reserve and a crucial tool in assisted reproductive technology ART for the evaluation of womens 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 testMann-Whitney U test for continuous variables and Chi-squareFishers exact test for categorical data Two-tailed P005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None