Treat of Functional Ovarian Cysts by Compare Between Cocs and Progesterone Only Pills

February 8, 2022 updated by: Abdelhamed Khaled Abdelhameed Farghal, Sohag University

Treatment of Functional Ovarian Cyst Randomised Clinical Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: mamdouh elsemary aaied, dr
  • Phone Number: 01062342515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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:
  • cyclo progynova
Drug: Progestin
effect of progestin in treatment of ovarian cystn
Other Names:
  • primalot-nor
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:
  • cyclo progynova
Drug: Progestin
effect of progestin in treatment of ovarian cystn
Other Names:
  • primalot-nor
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:
  • cyclo progynova
Drug: Progestin
effect of progestin in treatment of ovarian cystn
Other Names:
  • primalot-nor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment of functional ovarian cysts
Time Frame: one year
rate of treatment of combined oral contraceptive pills in functional ovarian cyst compared with cases who will receive progesterone only pills
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 20, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 8, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ovarian cysts

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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