Clinical Application of Serum Anti-Müllerian Hormone (AMH) Measurements
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Serum anti-Müllerian hormone (AMH) (pmol/L)
研究概览
简要总结
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:
- To study the level of serum AMH in women with PCOS and to evaluate the utility of serum AMH in the diagnosis of PCOS.
- To evaluate the level of serum AMH in women with POI and to evaluate the utility of serum AMH in the management of POI.
- To evaluate the associations of basal AMH level with FSH level and AFC respectively for women undergoing ART treatment.
- To determine the optimal regimen of gonadotropin for ovarian stimulation for women undergoing ART treatment.
- 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.
详细描述
[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 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 44 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women attending the Paediatric and Adolescent Gynaecological Clinic and Gynaecological Endocrine Clinic of in the Department of Obstetrics and Gynaecology at the Prince of Wales Hospital for the management of PCOS and POI
- •Women attending the Assisted Reproductive Technology (ART) Unit of The Chinese University of Hong Kong for ART treatment
排除标准
- •Women with age <10 or ≥45
- •Current or past diseases affecting gonadotropin, sex steroid secretion, clearance and excretion
结局指标
主要结局
Serum anti-Müllerian hormone (AMH) (pmol/L)
时间窗: Within 1 to 2 months after the day of recruitment
To evaluate the serum AMH level of women who undergo investigation for polycystic ovarian syndrome (PCOS), premature ovarian insufficiency (POI) or subfertility
次要结局
- Live birth rate(from 24 weeks of gestation up to 40 weeks)
- Total gonadotropin dose used for ovarian stimulation(On the last 1 day of ovarian stimulation during ART treatment)
- Type of gonadotropin used for ovarian stimulation(From the first 1 day to last 1 day of ovarian stimulation during ART treatment)
- Serum luteinising hormone (LH) (IU/L)(On the first 1 day of ovarian stimulation during ART treatment)
- Antral follicle count (AFC)(On the first 1 to 4 days of ovarian stimulation during ART treatment)
- Number of oocytes retrieved(On the 1 day of oocyte retrieval during ART treatment)
- Serum follicle stimulation hormone (FSH) (IU/L)(On the first 1 day of ovarian stimulation during ART treatment)
- Serum estradiol (pmol/L)(On the first 1 day of ovarian stimulation during ART treatment)
- Clinical pregnancy rate(6 to 7 weeks of gestation)
研究者
Chung Pui Wah Jacqueline
Associate Professor
Chinese University of Hong Kong
