The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01425333
• Other study ID #: R&D: DHRD/2010/089
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2011
• Last updated: August 26, 2011
• Start date: April 2011
• Est. completion date: February 2013

Study information

• Verified date: August 2011
• Source: Derby Hospitals NHS Foundation Trust
• Contact: Saad Amer, MD, MRCOG
• Phone: +44(1332)724612
• Email: saad[@]amer[@]nottigham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• Surgery for ovarian endometrioma
Patients undergoing surgery for ovarian endometrioma
• Surgery for ovarian endometrioma
Patients undergoing surgery for ovarian endometrioma

Locations

Country	Name	City	State
United Kingdom	Royal Derby Hospital	Derby

Sponsors (2)

Lead Sponsor	Collaborator
Saad Amer	Derby Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Mullerian Hormone (AMH)	Change in anti-mullerian hormone level after surgery (at one week, three months and six months)	6 months post-operatively	No
Secondary	Follicle Stimulating Hormone (FSH)	Change in follicle stimulating hormone levels after surgery (at one week, three months and six months)	6 months	No
Secondary	Antral Follicle Count (AFC)	Change in AFC after surgery (at three months)	3 months	No