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The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

Primary Purpose

Endometriosis

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Surgery for ovarian endometrioma
Surgery for ovarian endometrioma
Sponsored by
Saad Amer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Ovarian endometriomas, Laparoscopy, Cystectomy, Ablation

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Royal Derby HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cystectomy

Ablation

Arm Description

Patients undergoing cystectomy for ovarian endometrioma

Patients undergoing ablation for ovarian endometrioma

Outcomes

Primary Outcome Measures

Anti-Mullerian Hormone (AMH)
Change in anti-mullerian hormone level after surgery (at one week, three months and six months)

Secondary Outcome Measures

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

Full Information

First Posted
August 25, 2011
Last Updated
August 26, 2011
Sponsor
Saad Amer
Collaborators
University Hospitals of Derby and Burton NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01425333
Brief Title
The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Saad Amer
Collaborators
University Hospitals of Derby and Burton NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Ovarian endometriomas, Laparoscopy, Cystectomy, Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cystectomy
Arm Type
Active Comparator
Arm Description
Patients undergoing cystectomy for ovarian endometrioma
Arm Title
Ablation
Arm Type
Active Comparator
Arm Description
Patients undergoing ablation for ovarian endometrioma
Intervention Type
Procedure
Intervention Name(s)
Surgery for ovarian endometrioma
Other Intervention Name(s)
Patients undergoing cystectomy for ovarian endometrioma
Intervention Description
Patients undergoing surgery for ovarian endometrioma
Intervention Type
Procedure
Intervention Name(s)
Surgery for ovarian endometrioma
Other Intervention Name(s)
Patients undergoing cystectomy for ovarian endometrioma
Intervention Description
Patients undergoing surgery for ovarian endometrioma
Primary Outcome Measure Information:
Title
Anti-Mullerian Hormone (AMH)
Description
Change in anti-mullerian hormone level after surgery (at one week, three months and six months)
Time Frame
6 months post-operatively
Secondary Outcome Measure Information:
Title
Follicle Stimulating Hormone (FSH)
Description
Change in follicle stimulating hormone levels after surgery (at one week, three months and six months)
Time Frame
6 months
Title
Antral Follicle Count (AFC)
Description
Change in AFC after surgery (at three months)
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saad Amer, MD, MRCOG
Phone
+44(1332)724612
Email
saad@amer@nottigham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad Amer, MD, MRCOG
Organizational Affiliation
University of Nottingham and Derby Hospitals NHS foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Derby Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saad Amer, MD, MRCOG
Phone
+44(1332)724612
Email
saad.amer@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Francesca Raffi, MBChB, MRCOG

12. IPD Sharing Statement

Learn more about this trial

The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

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