The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

August 26, 2011 updated by: Saad Amer

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Derby, United Kingdom, DE22 3NE
        • Recruiting
        • Royal Derby Hospital
        • Contact:
        • Contact:
          • Francesca Raffi, MBChB, MRCOG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cystectomy
Patients undergoing cystectomy for ovarian endometrioma
Procedure: Surgery for ovarian endometrioma
Patients undergoing surgery for ovarian endometrioma
Other Names:
  • Patients undergoing cystectomy for ovarian endometrioma
ACTIVE_COMPARATOR: Ablation
Patients undergoing ablation for ovarian endometrioma
Procedure: Surgery for ovarian endometrioma
Patients undergoing surgery for ovarian endometrioma
Other Names:
  • Patients undergoing cystectomy for ovarian endometrioma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Mullerian Hormone (AMH)
Time Frame: 6 months post-operatively
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)
Time Frame: 6 months
Change in follicle stimulating hormone levels after surgery (at one week, three months and six months)
6 months
Antral Follicle Count (AFC)
Time Frame: 3 months
Change in AFC after surgery (at three months)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saad Amer

Collaborators

University Hospitals of Derby and Burton NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ANTICIPATED)

August 1, 2012

Study Completion (ANTICIPATED)

February 1, 2013

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

August 26, 2011

First Posted (ESTIMATE)

August 30, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2011

Last Update Submitted That Met QC Criteria

August 26, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R&D: DHRD/2010/089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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