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The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

This study is currently recruiting participants.
Verified August 2011 by Derby Hospitals NHS Foundation Trust
Sponsor:
Collaborator:
Derby Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Saad Amer, Derby Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01425333
First received: August 25, 2011
Last updated: August 26, 2011
Last verified: August 2011
History of Changes

August 25, 2011
August 26, 2011
April 2011
August 2012   (final data collection date for primary outcome measure)
Anti-Mullerian Hormone (AMH) [ Time Frame: 6 months post-operatively ] [ Designated as safety issue: No ]
Change in anti-mullerian hormone level after surgery (at one week, three months and six months)
Same as current
Complete list of historical versions of study NCT01425333 on ClinicalTrials.gov Archive Site
  • Follicle Stimulating Hormone (FSH) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change in follicle stimulating hormone levels after surgery (at one week, three months and six months)
  • Antral Follicle Count (AFC) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in AFC after surgery (at three months)
Same as current
Not Provided
Not Provided
 
The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometriosis
Procedure: Surgery for ovarian endometrioma
Patients undergoing surgery for ovarian endometrioma
Other Name: Patients undergoing cystectomy for ovarian endometrioma
  • Active Comparator: Cystectomy
    Patients undergoing cystectomy for ovarian endometrioma
    Intervention: Procedure: Surgery for ovarian endometrioma
  • Active Comparator: Ablation
    Patients undergoing ablation for ovarian endometrioma
    Intervention: Procedure: Surgery for ovarian endometrioma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
February 2013
August 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 42 Years
Yes
Contact: Saad Amer, MD, MRCOG +44(1332)724612 saad@amer@nottigham.ac.uk
United Kingdom
 
NCT01425333
R&D: DHRD/2010/089
Yes
Saad Amer, Derby Hospitals NHS Foundation Trust
Saad Amer
Derby Hospitals NHS Foundation Trust
Principal Investigator: Saad Amer, MD, MRCOG University of Nottingham and Derby Hospitals NHS foundation Trust
Derby Hospitals NHS Foundation Trust
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP