Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma

Study Overview
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Brief Summary
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The aim of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on ovarian reserve and pelvic pain in cases of ovarian endometrioma.

Detailed Description
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All patients are presenting with ovarian endometrioma. They are all subjected to informed written consent, full history, general examination, local examination and transvaginal ultrasound. Follicular stimulating hormone (FSH), Lutenizing hormone (LH), Anti Mullerian hormone (AMH), Antral follicular count (AFC) and chronic pelvic pain which is assessed by Visual Analogue Scale (VAS) of pain scoring system ,all are to be determined before and after laparoscopic surgery (postoperative three months); for two groups (Group A) cystectomy and (Group B) aspiration and coagulation. Histopathological examination was done to the cystectomy group to confirm endometriosis and detect the presence of healthy ovarian tissue in the excised cyst wall.

Official Title
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Impact of Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation on Ovarian Reserve and Pelvic Pain in Cases of Ovarian Endometrioma

Conditions
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Ovarian Endometrioma

Intervention / Treatment
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* Procedure: ovarian cystectomy
* Procedure: ovarian cyst aspiration and coagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female with age group 20-40 years. Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥3cm. Exclusion Criteria: Previous ovarian surgery. Endocrinological diseases affecting ovarian reserve e.g. Diabetes mellitus, hypothyroidism. Polycystic ovary syndrome (PCO). Suspicion of ovarian malignancy by ultrasound. Other pelvic pathology e.g. uterine fibroid, pelvic inflammatory disease (PID). High basal FSH >10mIU/mL (milli-international unit per milliliter).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ovarian cystectomy<br>laparoscopic ovarian cystectomy in endometrioma | Procedure: ovarian cystectomy<br>* laparoscopic ovarian cystectomy in endometrioma<br>|
| Experimental: ovarian cyst aspiration and coagulation<br>laparoscopic ovarian endometrioma aspiration and coagulation | Procedure: ovarian cyst aspiration and coagulation<br>* laparoscopic ovarian cyst aspiration and coagulation in endometrioma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve . | Evaluation of ovarian reserve which is measured by Anti Mullerian hormone (AMH) in nano-gram per milliliter (ng/ml) before laparoscopy and after the surgery by 3 months. | 3 months after laparoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Antral Follicular Count (AFC) as a measurement of ovarian reserve. | Evaluation of ovarian reserve by assessment of Antral Follicular Count (AFC) by measuring the number of visible ovarian follicles (2-10 mm mean diameter) that are observed during transvaginal ultrasonography in the early follicular phase (cycle days 2-5) in both ovaries. It is done before laparoscopy and after the surgery by 3 months. | 3 months after laparoscopy | 
| Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on chronic pelvic pain. | Pelvic pain is measured by Visual analogue scale of pain (VAS) which is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10-cm scale). The pelvic pain is assessed before laparoscopy and after laparoscopy by 3 months. | 3 months after laparoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrioma, laparoscopy, ovarian reserve, pelvic pain