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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
  Purpose

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.


Condition Intervention
Endometriosis
 Procedure: Surgery for ovarian endometrioma

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Further study details as provided by Derby Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 20
Study Start Date: April 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cystectomy
Patients undergoing cystectomy for ovarian endometrioma
 Procedure: Surgery for ovarian endometrioma
Patients undergoing surgery for ovarian endometrioma
Other Name: 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 Name: Patients undergoing cystectomy for ovarian endometrioma

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425333

Contacts
Contact: Saad Amer, MD, MRCOG +44(1332)724612 saad@amer@nottigham.ac.uk

Locations
United Kingdom
Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Contact: Saad Amer, MD, MRCOG     +44(1332)724612     saad.amer@nottingham.ac.uk    
Contact: Francesca Raffi, MBChB, MRCOG            
Sponsors and Collaborators
Saad Amer
Derby Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Saad Amer, MD, MRCOG University of Nottingham and Derby Hospitals NHS foundation Trust
  More Information

No publications provided

Responsible Party: Saad Amer, Associate Professor in Gynaecology, Derby Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01425333     History of Changes
Other Study ID Numbers: R&D: DHRD/2010/089
Study First Received: August 25, 2011
Last Updated: August 26, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Derby Hospitals NHS Foundation Trust:
Ovarian endometriomas
Laparoscopy
Cystectomy
Ablation

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013