|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01425333 |
|
Date of registration:
|
25/08/2011 |
|
Primary sponsor: |
|
|
Public title:
|
The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve
|
|
Scientific 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 |
|
Date of first enrolment:
|
April 2011 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01425333 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
Saad Amer, MD, MRCOG |
|
Address:
|
|
|
Telephone:
|
+44(1332)724612 |
|
Email:
|
saad.amer@nottingham.ac.uk |
|
Affiliation:
|
|
|
|
Name:
|
Saad Amer, MD, MRCOG |
|
Address:
|
|
|
Telephone:
|
+44(1332)724612 |
|
Email:
|
saad@amer@nottigham.ac.uk |
|
Affiliation:
|
|
|
|
Name:
|
Saad Amer, MD, MRCOG |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Nottingham and Derby Hospitals NHS foundation Trust |
|
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
42 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Endometriosis
|
|
Intervention(s)
|
|
Procedure: Surgery for ovarian endometrioma
|
|
Primary Outcome(s)
|
|
Anti-Mullerian Hormone (AMH)
[Time Frame: 6 months post-operatively]
|
|
Secondary Outcome(s)
|
|
Antral Follicle Count (AFC)
[Time Frame: 3 months]
|
|
Follicle Stimulating Hormone (FSH)
[Time Frame: 6 months]
|
|
Secondary ID(s)
|
|
R&D: DHRD/2010/089
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|