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临床试验/NCT02644304
NCT02644304Unknown2 期

Clomiphene Citrate Plus Cabergoline Versus Clomiphene Citrate Alone in Treatment of Polycystic Ovary Syndrome Associated Infertility

Woman's Health University Hospital, Egypt1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2015年5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
88
试验地点
1
主要终点
Size of mature follicles (mm).

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive aged women and affects approximately 5-12 % of the female population.

In 2003 in Rotterdam , Rotterdam diagnostic criteria were redefined PCOS as affected individuals must have two out of the following three criteria:

  1. Oligo- and/or anovulation, (ovulation occurs less than once every 35 days).
  2. Hyperandrogenism, clinical signs include hirsutism, acne, alopecia, and frank virilization, while chemical indicators include raised concentrations of total testosterone and androstenedione , and elevated free androgen index.
  3. Polycystic ovaries on sonographic examination, presence of 12 or more follicles in either ovary measuring 2-9 mm in diameter, increased ovarian volume more than 10 cm3 and/or increase in stromal echogenicity. Clearly, according to the Rotterdam diagnostic criteria, the majority of women with PCOS can be diagnosed without the need of laboratory examinations.

Clomiphene citrate (CC) is still the first-line medication for the induction of ovulation. It is an anti-estrogenic compound made up of two isomers, enclomiphene and zuclomiphene; the latter being the more potent of the two. It is a non-steroidal compound closely resembling estrogen. CC acts by blocking estrogen receptors, particularly in the hypothalamus, thereby signaling a lack of circulating estrogens and inducing a change in the pulsatile release of gonadotrophin-releasing hormone (GnRH). This induces release of follicle stimulating hormone from the anterior pituitary and is often enough to set the cycle of events leading to ovulation into motion.

Cabergoline, ergot-derived dopamine agonists with a very long half life, is an effective prolactin suppressor. Cabergoline oral administration contains a weekly dose of 0.5 - 3 mg, which could be increased, if needed, to twice a week. This medicine has slight dopamine agonistic side effects, headache being the most common one. Treatment in the very beginning should start with a partial dose (half a pill) at bedtime with a small amount of food. Low incidence of side effects and its weekly dose has made Cabergoline a choice drug for treatment of related diseases.

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
Double (Participant, Investigator)

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

  • 2 or more of PCOS signs according to Rotterdam diagnostic criteria (2003).-
  • Primary or secondary infertility.-
  • Absence of galactorrhoea
  • Normal serum prolactin or slightly elevated (up to 50 ng/dl)
  • Normal hysterosalpingography
  • Normal spermogram

排除标准

  • Women on other line of treatment as aromatase inhibitors, gonadotrophins, or tamoxifen.
  • Known hypersensitivity for Clomiphene citrate or cabergoline.
  • Other factors of infertility as tubal factor, uterine factor or male factor.

研究组 & 干预措施

Clomiphene citrate plus cabergoline

Active Comparator

This group will receive Clomiphene citrate 50 mg tablet twice daily from the second day of menses to the sixth day plus cabergoline 0.25 mg from second day every 3 days (4 doses only)

干预措施: Clomiphene citrate (Drug)

Clomiphene citrate plus cabergoline

Active Comparator

This group will receive Clomiphene citrate 50 mg tablet twice daily from the second day of menses to the sixth day plus cabergoline 0.25 mg from second day every 3 days (4 doses only)

干预措施: Cabergoline (Drug)

Clomiphene citrate plus placebo

Active Comparator

This group will receive Clomiphene citrate 50 mg tablet twice daily from the second day of menses to the sixth day plus placebo tablets from second day every 3 days (4 doses only)

干预措施: Clomiphene citrate (Drug)

Clomiphene citrate plus placebo

Active Comparator

This group will receive Clomiphene citrate 50 mg tablet twice daily from the second day of menses to the sixth day plus placebo tablets from second day every 3 days (4 doses only)

干预措施: Placebo (Other)

结局指标

主要结局

Size of mature follicles (mm).

时间窗: 1 year

次要结局

  • Number of mature follicles (mm)(1 year)
  • Number of pregnancy(1 year)

研究者

发起方
Woman's Health University Hospital, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kamal Mohamed Zahran

Dr

Woman's Health University Hospital, Egypt

研究点 (1)

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