跳至主要内容
临床试验/CTRI/2018/05/014207
CTRI/2018/05/014207招募中不适用

Comparison of ovarian reserve as measured by Anti Mullerian hormone and Antral Follicle Count between fertile and Infertile women in India.

MOTHER AND CHILD HOSPITAL1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年1月6日

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
comparison of Ovarian reserve between infertile and fertile women by AMH and AFC measurement.

研究概览

简要总结

AMH levels and AFC are considered the most sensitive and specific markers of ovarian reserve. They are used to predict response to ovarian stimulation by gonadotrophins during in-vitro fertilization. Ovarian reserve depletes with age though there is a great inter-individual variation in the rate of decrease. There is also an ongoing debate regarding the predictive ability of AMH and AFC for pregnancy and live birth outcome in IVF. AMH levels are often used to counsel infertile women on the need for early shift to IVF. Many researchers have brought to light the observation that AMH does not predict fecundity and that women with very low levels of AMH can conceive spontaneously. Ethnicity has been associated with altered age-specific levels of AMH. Women of Chinese, Black African, Hispanic and South Asian descent are reported to have a lower AMH at a given age compared with Caucasian women. Iglesias et al reported a  6-year age difference in ovarian reserve markers and ovarian response between Spanish and Indian women in favor of the Spanish, suggesting ethnic differences in ovarian aging. Whether this ethnic disparity reflects accelerated ovarian ageing or inherent genetic differences is unclear. A recent study by Hvidman et al 2016 looking at the same issue in Caucasian women found that the available number of growing antral follicles and their capability to produce AMH in the early follicular phase is the same in infertile patients and controls.Nutritional factors have been implicated to affect the ovarian reserve. There are conflicting data in literature  regarding the association  of Vitamin D  levels with the ovarian reserve markers .

Our study may elicit differences in ovarian reserve between fertile and infertile population in India and would help us to prepare age specific nomograms for AMH in both the fertile and infertile population .Our results may help clinicians to counsel infertile women when discussing assisted reproductive technology.

We would also like to assess the vitamin D levels in the fertile population and prepare nomograms for the same as it would help us in having an in depth understanding of the association of vitamin D with ovarian reserve markers.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 39.00 Year(s)(—)
性别
Female

入选标准

  • infertile women and fertile women with at least one child.

排除标准

  • Women with PCOS, unilateral oophorectomy, endometriosis grade 3&4,women taking vitamin D supplementation(in the fertile group).

结局指标

主要结局

comparison of Ovarian reserve between infertile and fertile women by AMH and AFC measurement.

时间窗: once

次要结局

  • build AMH normogram in fertile population(and Vitamin D nomogram in fertile population)

研究者

发起方
MOTHER AND CHILD HOSPITAL
申办方类型
Private hospital/clinic

研究点 (1)

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