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临床试验/NCT05244811
NCT05244811Unknown3 期

Treatment of Functional Ovarian Cyst Randomised Clinical Trial

Sohag University0 个研究点目标入组 60 人开始时间: 2022年2月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
60
主要终点
treatment of functional ovarian cysts

研究概览

简要总结

comparison between cocs and progesterone only containing pills in treatment of fuctional ovarian cyst

详细描述

Ovarian cyst is a blister-like sac, which is formed on the surface of ovary during or after ovulation . Most of them are made in reproductive age and are harmless ; these cysts do not cause any symptom and are resolved without treatment , but sometimes they cause health problems that require special attention, and even may lead to infertility. Normal function of ovary is the periodic release of ovums and the production of the steroid hormones of estradiol and progesterone . Both activities are integrated in the continuous repetitive process of follicle maturation, ovulation, and corpus luteum formation and regression. Mature follicle is ruptured and releases ovum during ovulation and corpus luteum is produced from empty follicle if pregnancy does not occur corpus luteum is regressed, due to the absence of hCG (human chorionic gonadotropin). Sometimes this procedure does not happen normally, which results in the formation of ovarian cysts Therefore, functional ovarian cysts are different from ovarian growths induced by other pathological problems most of them regress spontaneously in two or three cycles , but if a cyst gets large, it can twist, be ruptured, or bleed and become very painful .

A functional type of ovarian cyst forms because of slight changes in the way of making or releasing an ovum by the ovary . There are two types of such cysts:

  1. The follicular cyst, which occurs when the sac on ovary does not release an egg and the sac swells up with fluid
  2. The luteal cyst, which is formed when the sac releases an egg and then reseals and fills with fluid

Most functional ovarian cysts are asymptomatic , the larger the cyst, the more likely the symptom. The symptoms are pain or aching in lower abdomen, menstrual irregularity, vaginal bleeding, dyspareunia, etc.; sometimes the cyst is ruptured and causes peritoneal irritation with presentations such as nausea and vomiting or sudden onset of pain, hemorrhagic cyst, intra-abdominal bleeding, and emergency conditions . Some other manifestations such as nausea and vomiting may be felt before the occurrence of such events . Regular pelvic examination is recommended for some patients with the history of such cysts; they also may need regular sonography . Oral contraceptive pills (OCPs) are prescribed by some physician to shrink the cyst, if it is persistent and makes discomfort . Although it seems that they are not effective enough compared with close observation, and even some researchers reported no benefits for OCPs, some others prescribed them before any surgical practices ; therefore, the current study aimed at evaluating this issue. For this purpose, some patients who referred to a private clinic were selected in order to compare the effect of OCPs with close observation in the clinical management of functional ovarian cysts. dyspareunia, or the cysts may be found accidentally on voluntary sonography without any symptoms.

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
18 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The current randomized, clinical trial was performed on females with:-
  • functional ovarian cysts (4 to 8 cm in diameter)
  • in reproductive age, within the age range of 18 to 48 years, referred to the Clinic of Gynecological Diseases in a private hospital as outpatient The cysts were identified by transvaginal ultrasonography

排除标准

  • were history of:-
  • endometrioma.
  • Other non-functional .ovarian neoplasm
  • OCPs consumption during the last three months The patients were randomly divided into three equals

研究组 & 干预措施

use of placebo in treatment of functional ovarian cyst

Placebo Comparator

trial the effect of placebo in treatment of functional ovarian cyst

干预措施: Combined Oral Contraceptive (Drug)

use of placebo in treatment of functional ovarian cyst

Placebo Comparator

trial the effect of placebo in treatment of functional ovarian cyst

干预措施: Progestin (Drug)

use of cocs in treatment of functional ovarian cyst

Active Comparator

trial of the effectiveness of cocs in the treatment of functional ovarian cyst

干预措施: Combined Oral Contraceptive (Drug)

use of cocs in treatment of functional ovarian cyst

Active Comparator

trial of the effectiveness of cocs in the treatment of functional ovarian cyst

干预措施: Progestin (Drug)

use of progesterone in treatment of functional ovarian cyst

Active Comparator

comparison between the effect of progesterone in the treatment of functional ovarian cyst with the effect of cocs

干预措施: Combined Oral Contraceptive (Drug)

use of progesterone in treatment of functional ovarian cyst

Active Comparator

comparison between the effect of progesterone in the treatment of functional ovarian cyst with the effect of cocs

干预措施: Progestin (Drug)

结局指标

主要结局

treatment of functional ovarian cysts

时间窗: one year

rate of treatment of combined oral contraceptive pills in functional ovarian cyst compared with cases who will receive progesterone only pills

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

Abdelhamed Khaled Abdelhameed Farghal

resident doctor in gynaecology and obstetric department in nasser general hospital

Sohag University

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