The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

Study Overview
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Brief Summary
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The aim of this study is to assess which of two commonly used surgical procedures in the treatment of ovarian cysts called endometriomas (cutting out of the cyst - cystectomy, or draining it and cauterising it's inner lining - ablation) causes the least damage to the ovary and is therefore best at maintaining the future fertility potential of a patient.

Official Title
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The Impact of Surgical Treatment of Ovarian Endometriomas on Ovarian Reserve: a Randomised Controlled Trial of Laparoscopic Ovarian Cystectomy Versus Cyst Ablation - a Pilot Study

Conditions
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Endometriosis

Intervention / Treatment
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* Procedure: Surgery for ovarian endometrioma
* Procedure: Surgery for ovarian endometrioma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing laparoscopic surgery for treatment of unilateral endometriomas measuring ≥ 3cm and ≤ 8cm in diameter Exclusion Criteria: Patients who have received oestrogen suppressing drugs (e.g. oral contraceptive pills, GnRHa) during the previous six months Patients who have previously undergone surgical treatment of endometriomas Patients with bilateral endometriomas Patients with endometriomas of less than 3cm in size or more than 8cm in size Pre-surgical evidence of reduced ovarian reserve Pregnant patients Patients unable to give informed consent e.g. patients with mental incapacity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cystectomy<br>Patients undergoing cystectomy for ovarian endometrioma | Procedure: Surgery for ovarian endometrioma<br>* Patients undergoing surgery for ovarian endometrioma<br>* Other names: Patients undergoing cystectomy for ovarian endometrioma;|
| Active Comparator: Ablation<br>Patients undergoing ablation for ovarian endometrioma | Procedure: Surgery for ovarian endometrioma<br>* Patients undergoing surgery for ovarian endometrioma<br>* Other names: Patients undergoing cystectomy for ovarian endometrioma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Mullerian Hormone (AMH) | Change in anti-mullerian hormone level after surgery (at one week, three months and six months) | 6 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follicle Stimulating Hormone (FSH) | Change in follicle stimulating hormone levels after surgery (at one week, three months and six months) | 6 months | 
| Antral Follicle Count (AFC) | Change in AFC after surgery (at three months) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian endometriomas, Laparoscopy, Cystectomy, Ablation