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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
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The current randomized, clinical trial was performed on females with:-

    1. functional ovarian cysts (4 to 8 cm in diameter)
    2. 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:-

    1. endometrioma.
    2. Other non-functional .ovarian neoplasm
    3. 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

    First Posted
    January 9, 2022
    Last Updated
    February 8, 2022
    Sponsor
    Sohag University
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    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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