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临床试验/NCT03316469
NCT03316469Unknown不适用

Circulating Anti-mullerian Hormone as Predictor of Ovarian Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome

Ain Shams University0 个研究点目标入组 40 人开始时间: 2018年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
40
主要终点
AMH in prediction of Ovulation in women with PCOS.

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is found in 5% to 6% of women of reproductive age. It affects women's reproductive capability; thus patients have risks of infertility, miscarriage, and complicated pregnancy. A study revealed that the prevalence of oligoovulation or anovulation in patients with PCOS ranged from 65% to 80%. Anti-Mullerian Hormone (AMH) is an important regulator in the ovary that play a rule during development and function. It is suspected to affect clomiphene citrate (cc) resistance. In this study the investigator will assess the accuracy of AMH prediction of response to cc in women with PCOS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Screening
盲法
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with PCOS
  • Women 20-35 years old.
  • BMI ≤30 kg/m without previous ovulation induction.
  • Partners with normal semen parameters Parameter World Health Organization (WHO) 2010 Volume1.5 ml Concentration 15 million/ml Progressive motility 32% Normal forms 4%

排除标准

  • Women with evidence of hyper-or hypothyroidism, hyperprolactinemia, Cushing's syndrome, congenital adrenal hyperplasia or androgen-secreting tumors.
  • Women with factors of infertility other than PCOS
  • Women with incomplete data.

研究组 & 干预措施

Group A: CC & ovulation

Experimental

AMH level is measured before Clomiphene citrate 100 mg daily for 5 days & detecting Follicular growth assessment by TVU will be performed at day 12 of the menstrual period. Successful and unsuccessful follicular growth will be compared according to the subjects' respective AMH levels.

干预措施: Clomiphene Citrate (Drug)

Group A: CC & ovulation

Experimental

AMH level is measured before Clomiphene citrate 100 mg daily for 5 days & detecting Follicular growth assessment by TVU will be performed at day 12 of the menstrual period. Successful and unsuccessful follicular growth will be compared according to the subjects' respective AMH levels.

干预措施: Follicular growth (Diagnostic Test)

Group B: CC & no ovulation

Experimental

AMH level is measured before Clomiphene citrate 100 mg daily for 5 days & detecting Follicular growth assessment by TVU will be performed at day 12 of the menstrual period. Successful and unsuccessful follicular growth will be compared according to the subjects' respective AMH levels.

干预措施: Clomiphene Citrate (Drug)

Group B: CC & no ovulation

Experimental

AMH level is measured before Clomiphene citrate 100 mg daily for 5 days & detecting Follicular growth assessment by TVU will be performed at day 12 of the menstrual period. Successful and unsuccessful follicular growth will be compared according to the subjects' respective AMH levels.

干预措施: Follicular growth (Diagnostic Test)

结局指标

主要结局

AMH in prediction of Ovulation in women with PCOS.

时间窗: 10 days

AMH level is measured 10 days before expected date of ovulation then correlated to ovulation either successfully or not.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Narges Essam El-din Marrey

Resident of obs & gyn.

Ain Shams University

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