The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

Not Applicable

• Conditions: Endometriosis
• Interventions: Procedure: Surgery for ovarian endometrioma

• Registration Number: NCT01425333
• Lead Sponsor: Saad Amer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Status Verified: 2011-08
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-08-26
• Last Update Submitted: 2011-08-26
• Study First Posted: 2011-08-30
• Last Update Posted: 2011-08-30
• Primary Completion: 2012-08
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cystectomy	Surgery for ovarian endometrioma	Patients undergoing cystectomy for ovarian endometrioma
Ablation	Surgery for ovarian endometrioma	Patients undergoing ablation for ovarian endometrioma

Primary Outcome Measures

Name	Time	Method
Anti-Mullerian Hormone (AMH)	6 months post-operatively	Change in anti-mullerian hormone level after surgery (at one week, three months and six months)

Secondary Outcome Measures

Name	Time	Method
Follicle Stimulating Hormone (FSH)	6 months	Change in follicle stimulating hormone levels after surgery (at one week, three months and six months)
Antral Follicle Count (AFC)	3 months	Change in AFC after surgery (at three months)

Trial Locations

Locations (1)

Royal Derby Hospital; 🇬🇧 Derby, United Kingdom