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临床试验/NCT02237781
NCT02237781Unknown2 期

Prospective Randomized Trial on the Level of Anti-Mullerian Hormone (AMH) in Women Undergoing Controlled Ovarian Stimulation for IVFwith Gonadotropins.

University of Athens0 个研究点目标入组 50 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
50
主要终点
Level of AMH

研究概览

简要总结

Anti-Mullerian Hormone (AMH) is produced only in small ovarian follicles with quite stable levels during the cycle. There is not yet sufficient data to inform couples undergoing IVF about the effect of ovarian stimulation on the levels of AMH due to the increasing size of follicles and chances of success of the method.

详细描述

Patients undergoing IVF will be included in the study. All patients will be counseled regarding their prognosis. Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of IVF and during ovarian stimulation. Patients will be stimulated with a short GnRH-antagonist protocol. All women will have measurements of serum FSH and estradiol (E2) and a pelvic sonogram on the second day of their cycle. Ovarian stimulation will be initiated with of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH. The dose of gonadotropins will depend on the levels of estradiol and FSH prior stimulation. All patients will be re-evaluated on day 3 and 5 of the stimulation (measurment of AMH, E2 and pelvic sonogram), and dosage adjustments will be made and the antagonists (Cetrorelix or ganirelix 0.25 mg/day) will be initiated on day 5. Measurment of AMH, E2 and pelvic sonogram to conferm the size of follicles will be continue every second day untill the oocyte retrieval. When at least 2 follicles reach an average diameter of 17 mm, final oocyte maturation will be triggered with 10,000IU of hCG ( Pregnyl, Organon, Greece Inc.). Oocyte retrieval will be performed 34 to 36 hours later. Patients with successful fertilization will have embryo transfer under sonographic guidance on day 3 after retrieval.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All infertile women undergoing ovarian stimulation for IVF.

排除标准

  • Women who can not undergo IVF

研究组 & 干预措施

AMH levels

Experimental

Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists. Levels of AMH will be measured prior and during the ovarian stimulation.

干预措施: Gonadotropins (Drug)

结局指标

主要结局

Level of AMH

时间窗: 6 months

Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment and during ovarian stimulation.

次要结局

未报告次要终点

研究者

发起方
University of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nikos Vlahos

Associate Professor of Obstetrics and Gynecology

University of Athens

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