The Impact of Surgical Treatment of Endometriomas on Ovar... | NCT01425333

Studies
The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

NCT01425333

Sponsor

Saad Amer

Status

Unknown status

Last Update Posted

Aug 30, 2011Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Endometriosis

Interventions

Surgery for ovarian endometrioma
Surgery for ovarian endometrioma

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Aug 2012Estimated

Completion Date

Feb 2013Estimated

First Submitted Date

Aug 25, 2011

First Submission Date that Met QC Criteria

Aug 26, 2011

First Posted Date

Aug 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2011

Last Update Posted Date

Aug 30, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Saad Amer, Associate Professor in Gynaecology, University Hospitals of Derby and Burton NHS Foundation TrustSponsor-Investigator

Lead Sponsor

Saad AmerOTHER

Collaborators

Name	Class
University Hospitals of Derby and Burton NHS Foundation Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cystectomy	Active Comparator	Patients undergoing cystectomy for ovarian endometrioma	Procedure: Surgery for ovarian endometrioma
Ablation	Active Comparator	Patients undergoing ablation for ovarian endometrioma	Procedure: Surgery for ovarian endometrioma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery for ovarian endometrioma	Procedure	Patients undergoing surgery for ovarian endometrioma	Cystectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-Mullerian Hormone (AMH)	Change in anti-mullerian hormone level after surgery (at one week, three months and six months)	6 months post-operatively

Secondary Outcomes

Measure	Description	Time Frame
Follicle Stimulating Hormone (FSH)	Change in follicle stimulating hormone levels after surgery (at one week, three months and six months)	6 months
Antral Follicle Count (AFC)	Change in AFC after surgery (at three months)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Saad Amer, MD, MRCOG	Contact	+44(1332)724612		saad@amer@nottigham.ac.uk

Overall Officials

Name	Affiliation	Role
Saad Amer, MD, MRCOG	University of Nottingham and Derby Hospitals NHS foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Derby Hospital	Recruiting	Derby		DE22 3NE	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided