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临床试验/NCT02024984
NCT02024984Unknown1 期

Luteal Phase Versus Follicular Phase Administration of Clomiphene Citrate in PCOS, A Randomized Controlled Trial

Ain Shams Maternity Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
90
试验地点
1
主要终点
the total number of follicles, number of follicles > 14 mm in diameter, number of follicles > 18 mm in diameter.

研究概览

简要总结

INTRODUCTION Polycystic ovary syndrome (PCOS) is one of the most common female endocrine disorders (Fauser et al., 2011). It is a complex, heterogeneous disorder of uncertain aetiology, but there is strong evidence that it can, to a large degree, be classified as a genetic disease (Fauser et al., 2011). Genetic and environmental contributors to hormonal disturbances combine with other factors, including obesity (Diamanti-Kandarakis et al., 2006). Ovarian dysfunction and hypothalamic pituitary abnormalities contribute to the etiology of PCOS (Doi et al., 2005).

It produces symptoms in approximately 5% to 10% of women of reproductive age (12-45 years old). It is thought to be one of the leading causes of female subfertility (Goldenberg and Glueck, 2008).

Its prevalence has increased with the use of different diagnostic criteria and has recently been shown to be 18% (17.8 ± 2.8%) in the first community-based prevalence study based on current Rotterdam diagnostic criteria (March et al., 2010).

AIM OF THE WORK The study will compare the luteal phase (early) administration of clomiphene citrate to the conventional (late) administration of the same drug in the follicular phase as regards ovarian response in PCOS.

Research Question What is the difference between administration of clomiphene citrate in the luteal phase and the follicular phase for ovulation induction in women with PCOS? Research Hypothesis Luteal phase administration of clomiphene citrate protocol gives better results than conventional administration of clomiphene citrate in the follicular phase as regards ovarian response in PCOS.

详细描述

AIM OF THE WORK The study will compare the luteal phase (early) administration of clomiphene citrate to the conventional (late) administration of the same drug in the follicular phase as regards ovarian response in PCOS.

Research Question What is the difference between administration of clomiphene citrate in the luteal phase and the follicular phase for ovulation induction in women with PCOS? Research Hypothesis Luteal phase administration of clomiphene citrate protocol gives better results than conventional administration of clomiphene citrate in the follicular phase as regards ovarian response in PCOS.

Subjects and methods

Study design:

This prospective crossover randomized controlled clinical trial will be conducted in infertility outpatient clinic in Ain Shams Maternity Hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • A. Women aged 20-40 years old.
  • B. Patients with diagnosis of PCOS based on the 2003 ESHRE/ASRM (Rotterdam) criteria: to include two of the following, in addition to exclusion of related disorders:
  • Oligo / anovulation
  • Hyperandrogenism and/or Hyperandrogenemia
  • Polycystic ovaries by U/S i.e. at least one ovary showing either 1 - 12 more follicles (2-9 mm in diameter) or ovarian volume > 10 mm.

排除标准

  • A. Age < 20 or >
  • B. Major pelvic pathology. C. Ovarian masses. D. Infertility due to causes other than ovarian factors e.g.
  • Bilateral tubal block
  • Congenital anomaly of the uterus
  • Male factor of infertility E. Liver disease F. Other endocrinopathies e.g. hyperprolactinemia, Lipoid Congenital Adrenal Hyperplasia (LCAH), hypothyroidism, hyperthyroidism and Cushing's disease.

研究组 & 干预措施

Group A

Experimental

Luteal Phase Administration of Clomiphene (50mg twice per day for 5 days)

干预措施: Clomiphene Citrate (Drug)

Group B

Active Comparator

Follicular Phase Administration of Clomiphene Citrate in PCOS(50mg twice per day for 5 days)

干预措施: Clomiphene Citrate (Drug)

结局指标

主要结局

the total number of follicles, number of follicles > 14 mm in diameter, number of follicles > 18 mm in diameter.

时间窗: 6 months

the total number of follicles, number of follicles \> 14 mm in diameter, number of follicles \> 18 mm in diameter.

次要结局

  • endometrial thickness(6 months)

研究者

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

Ahmed E Elbohoty, MD

Lecturer in OB GYN

Ain Shams Maternity Hospital

研究点 (1)

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