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临床试验/NCT00844350
NCT00844350已完成2 期

The Effect of Oxytocin (OT) and Oxytocin Plus Human Chorionic Gonadotropin (hCG), in Cycles Induced by Letrozole or Clomiphene Citrate

Tabriz University0 个研究点目标入组 177 人开始时间: 2006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
状态
已完成
发起方
入组人数
177
主要终点
number of follicles, endometrial thickness, and clinical pregnancy rate

研究概览

简要总结

The specific aims of this study were to assess whether letrozole as an aromatase inhibitor plus hCG or OT alone, or in combination compared with CC, improves ovarian response.Ethical design of this study is based on the ethical guidelines of the Iranian Medical and Health Ministry which is accepted by Tabriz medical university ethical committee .

详细描述

In a randomized controlled prospective clinical study, a total of 177 infertile women with CC+hCG-resistant PCOS included. The candidates were selected for this study in the clinics of Tabriz University of Medical Sciences, East Azarbayejan Province, North West of Iran, from Oct. 2006 to Sep. 2007. Infertile women who had chronic anovulation and classical PCOS with CC+hCG failure were age <40 y , had patent tubes on hysterosalpingography, and no other pelvic pathology, participated in this study. The patients who had hypersensivity to any oxytocic medications, history of cardiovascular disease, and took anti-hypertensive medications were excluded. In addition, women with blood pressure less than 90/60 mmHg, abnormal spermogram, anxiety, excess prolactin levels, and other causes of infertility were excluded. All participants were given adequate information, and consent was obtained from each participant.

The candidates were randomly divided into five groups including; letrozole + hCG (36 patients) (group 1), letrozole + OT (35 patients) (group 2), letrozole +OT + hCG (35 patients) (group 3), CC + OT (35 patients) (group 4), and CC + OT + hCG (36 patients) (group 5). Participants received letrozole 2.5mg at first month and 5mg at the second and third month. Also, CC was used 50 mg at the first month, to 150 mg at the third month to stimulate follicular growth. Oxytocin (OXYTIP; manufactured by IPDIC, Rasht, Iran), 5 IU and hCG (Choriomon; manufactured by IBSA Institute Biochimique SA, CH-6903 Lugano), 5000 IU were also administrated to induce ovulation. All patients underwent transvaginal sonography on day 13 to document the numbers of follicles and endometrial thickness. Participants were evaluated for three courses of intervention. Oxytocin was injected intramuscularly after CC or letrozol stimulation had induced enlarged ovarian follicles ( >18 mm in diameter to 30 mm). Decision to give a 5 IU dose of OT was made according to the pilot study (30). The patients who had larger follicles (more than 30mm in diameter), were withdrawn. The patients, who achieved pregnancy at the first or second month, were also withdrawn. All participants were evaluated for the levels of plasma progesterone one week after the injection of OT, hCG, or combination of them. A follow-up visit was arranged for each group every month at the second day of menstruation until 3 months after recruitment or at any time during the trial if pregnancy was achieved.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
17 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • infertile women who had chronic anovulation
  • classical PCOS with CC+hCG failure
  • age <40 y
  • had patent tubes on hysterosalpingography
  • no other pelvic pathology
  • participated in this study

排除标准

  • hypersensitivity to any oxytocic medications
  • history of cardiovascular disease
  • took anti-hypertensive medications were excluded.
  • women with blood pressure less than 90/60 mmHg
  • abnormal spermogram
  • excess prolactin levels
  • other causes of infertility were excluded

研究组 & 干预措施

letrozole+hCG

No Intervention

干预措施: letrozole , oxytocin,hCG,clomiphene citrate (Drug)

letrozole+oxytocin

No Intervention

干预措施: letrozole , oxytocin,hCG,clomiphene citrate (Drug)

letrozole+oxytocin+hCG

No Intervention

干预措施: letrozole , oxytocin,hCG,clomiphene citrate (Drug)

clomiphene citrate +oxytocin

No Intervention

干预措施: letrozole , oxytocin,hCG,clomiphene citrate (Drug)

clomiphene citrate +oxytocin+hCG

No Intervention

干预措施: letrozole , oxytocin,hCG,clomiphene citrate (Drug)

结局指标

主要结局

number of follicles, endometrial thickness, and clinical pregnancy rate

时间窗: first ,second and third month

次要结局

未报告次要终点

研究者

发起方
Tabriz University
申办方类型
Other

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