Treat of Functional Ovarian Cysts by Compare Between Cocs and Progesterone Only Pills
Primary Purpose
Ovarian Neoplasms
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Combined Oral Contraceptive
Progestin
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Neoplasms
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
were history of:-
- endometrioma.
- Other non-functional .ovarian neoplasm
- OCPs consumption during the last three months The patients were randomly divided into three equals
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
use of placebo in treatment of functional ovarian cyst
use of cocs in treatment of functional ovarian cyst
use of progesterone in treatment of functional ovarian cyst
Arm Description
trial the effect of placebo in treatment of functional ovarian cyst
trial of the effectiveness of cocs in the treatment of functional ovarian cyst
comparison between the effect of progesterone in the treatment of functional ovarian cyst with the effect of cocs
Outcomes
Primary Outcome Measures
treatment of functional ovarian cysts
rate of treatment of combined oral contraceptive pills in functional ovarian cyst compared with cases who will receive progesterone only pills
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05244811
Brief Title
Treat of Functional Ovarian Cysts by Compare Between Cocs and Progesterone Only Pills
Official Title
Treatment of Functional Ovarian Cyst Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 20, 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
comparison between cocs and progesterone only containing pills in treatment of fuctional ovarian cyst
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:
The follicular cyst, which occurs when the sac on ovary does not release an egg and the sac swells up with fluid
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
use of placebo in treatment of functional ovarian cyst
Arm Type
Placebo Comparator
Arm Description
trial the effect of placebo in treatment of functional ovarian cyst
Arm Title
use of cocs in treatment of functional ovarian cyst
Arm Type
Active Comparator
Arm Description
trial of the effectiveness of cocs in the treatment of functional ovarian cyst
Arm Title
use of progesterone in treatment of functional ovarian cyst
Arm Type
Active Comparator
Arm Description
comparison between the effect of progesterone in the treatment of functional ovarian cyst with the effect of cocs
Intervention Type
Drug
Intervention Name(s)
Combined Oral Contraceptive
Other Intervention Name(s)
cyclo progynova
Intervention Description
effect of cocs in treatment of ovarian cysts
Intervention Type
Drug
Intervention Name(s)
Progestin
Other Intervention Name(s)
primalot-nor
Intervention Description
effect of progestin in treatment of ovarian cystn
Primary Outcome Measure Information:
Title
treatment of functional ovarian cysts
Description
rate of treatment of combined oral contraceptive pills in functional ovarian cyst compared with cases who will receive progesterone only pills
Time Frame
one year
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
were history of:-
endometrioma.
Other non-functional .ovarian neoplasm
OCPs consumption during the last three months The patients were randomly divided into three equals
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
salah mohamed rasheed, professor
Phone
01224653702
Email
salahrasheed67@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
mamdouh elsemary aaied, dr
Phone
01062342515
12. IPD Sharing Statement
Citations:
PubMed Identifier
25670222
Citation
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.
Results Reference
background
PubMed Identifier
28655015
Citation
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.
Results Reference
background
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Treat of Functional Ovarian Cysts by Compare Between Cocs and Progesterone Only Pills
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