Treat of Functional Ovarian Cysts by Compare Between Cocs and Progesterone Only Pills
Study Details
Study Description
Brief Summary
comparison between cocs and progesterone only containing pills in treatment of fuctional ovarian cyst
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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:
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The follicular cyst, which occurs when the sac on ovary does not release an egg and the sac swells up with fluid
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: use of placebo in treatment of functional ovarian cyst trial the effect of placebo in treatment of functional ovarian cyst |
Drug: Combined Oral Contraceptive
effect of cocs in treatment of ovarian cysts
Other Names:
Drug: Progestin
effect of progestin in treatment of ovarian cystn
Other Names:
|
| Active Comparator: use of cocs in treatment of functional ovarian cyst trial of the effectiveness of cocs in the treatment of functional ovarian cyst |
Drug: Combined Oral Contraceptive
effect of cocs in treatment of ovarian cysts
Other Names:
Drug: Progestin
effect of progestin in treatment of ovarian cystn
Other Names:
|
| Active Comparator: use of progesterone in treatment of functional ovarian cyst comparison between the effect of progesterone in the treatment of functional ovarian cyst with the effect of cocs |
Drug: Combined Oral Contraceptive
effect of cocs in treatment of ovarian cysts
Other Names:
Drug: Progestin
effect of progestin in treatment of ovarian cystn
Other Names:
|
Outcome Measures
Primary Outcome Measures
- treatment of functional ovarian cysts [one year]
rate of treatment of combined oral contraceptive pills in functional ovarian cyst compared with cases who will receive progesterone only pills
Eligibility Criteria
Criteria
Inclusion Criteria:
- The current randomized, clinical trial was performed on females with:-
-
functional ovarian cysts (4 to 8 cm in diameter)
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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
Exclusion Criteria:
- were history of:-
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endometrioma.
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Other non-functional .ovarian neoplasm
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OCPs consumption during the last three months The patients were randomly divided into three equals
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sohag University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Formuso C, Stracquadanio M, Ciotta L. Myo-inositol vs. D-chiro inositol in PCOS treatment. Minerva Ginecol. 2015 Aug;67(4):321-5. Epub 2015 Feb 11.
- Wu XK, Stener-Victorin E, Kuang HY, Ma HL, Gao JS, Xie LZ, Hou LH, Hu ZX, Shao XG, Ge J, Zhang JF, Xue HY, Xu XF, Liang RN, Ma HX, Yang HW, Li WL, Huang DM, Sun Y, Hao CF, Du SM, Yang ZW, Wang X, Yan Y, Chen XH, Fu P, Ding CF, Gao YQ, Zhou ZM, Wang CC, Wu TX, Liu JP, Ng EHY, Legro RS, Zhang H; PCOSAct Study Group. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2502-2514. doi: 10.1001/jama.2017.7217.
- ovarian cysts