The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

Study Overview
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Brief Summary
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The aim of this study is to determine whether the use of progesterone only pills has a beneficial effect over the expectant management of functional ovarian cyst or not , through a sample of female patients within the reproductive years

Detailed Description
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An ovarian cyst is a common gynecological problem and is divided into 2 main categories; physiological and pathological In relative frequency, functional cysts account for about 24% of all ovarian cysts, benign cysts 70% and malignant 6% Functional cysts are the most common masses seen in the premenopausal ovary and are estimated to affect 8%-20% of reproductive-aged women Pain or discomfort in the lower abdomen Severe pain from torsion (twisting) or rupture - Cyst rupture is characterized by sudden, sharp, unilateral pelvic pain; this can be associated with trauma, exercise, or coitus. Cyst rupture can lead to peritoneal signs, abdominal distention, and bleeding (which is usually self-limited) Discomfort with intercourse, particularly deep penetration Changes in bowel movements such as constipation Pelvic pressure causing tenesmus or urinary frequency Menstrual irregularities Precocious puberty and early menarche in young children Abdominal fullness and bloating Indigestion, heartburn, or early satiety Hyperpyrexia - This may result from some complications of ovarian cysts, such as ovarian torsion Adnexal or cervical motion tenderness In current clinical practice , gynecologists treat functional ovarian cysts with either oral Contraceptive pills or expectant management alone. we presume using progesterone only pills for treatment of functional ovarian cyst

Official Title
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The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

Conditions
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Progesterone, Functional Ovarian Cyst

Intervention / Treatment
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* Drug: Dydrogesterone 10 mg
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients at reproductive age (18-44) Menstruating ovarian cyst (a cyst 3-10 cm in diameter, unilateral , unilocular ,clear content) BMI : patients with normal BMI (18.5-24.9) and overweight (25-29.9) included Exclusion Criteria: Exclusion criteria are ovarian payhology (dermoid, endometriosis or malignancies) Complicated cyst (rupture, torsion) Patients receiving hormonal treatment for the previous 3 cycles History of surgical removal of ovarian cyst Comorbidities like uncontrolled DM ,hypertension and tuberculosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: progesterone<br>these patients will be offered Dydrogesterone 10 mg twice daily will be offered for 10 days , then they will be seen Post-menstrual or delayed menses for 1 week after treatment | Drug: Dydrogesterone 10 mg<br>* Dydrogesterone 10 mg twice daily<br>* Other names: duphaston 10 mg;|
| Placebo Comparator: placebo<br>those patients will be offered placebo tablets twice daily will be offered for 10 days , then they will be seen Post-menstrual or delayed menses for 1 week after treatment | Drug: Placebo Oral Tablet<br>* oral tablets twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disappearance of cyst | ultrasound evaluation Post-menstrual or delayed menses for 1 week after treatment Patients will be asked about residual symptoms Then TVUS if resolved , another examination will be scheduled after 1 month post-menstrual decreasing in size , another course of treatment will be offered stationary or increasing ,patient will be offered COCs (0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol) complicated ( torsion or rupture ) , patient will be subjected to surgery | 2 months |