NCT01425333

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

Enrollment Period

1.3 years

First QC Date

August 25, 2011

Last Update Submit

August 26, 2011

Conditions

Endometriosis

Keywords

Ovarian endometriomasLaparoscopyCystectomyAblation

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Follicle Stimulating Hormone (FSH)

    6 months

  • Antral Follicle Count (AFC)

    3 months

Study Arms (2)

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

Surgery for ovarian endometriomaPROCEDURE

Patients undergoing surgery for ovarian endometrioma

Also known as: Patients undergoing cystectomy for ovarian endometrioma
Cystectomy

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing laparoscopic surgery for treatment of unilateral endometriomas measuring ≥ 3cm and ≤ 8cm in diameter

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Derby Hospital

Derby, DE22 3NE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Saad Amer, MD, MRCOG

    University of Nottingham and Derby Hospitals NHS foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saad Amer, MD, MRCOG

CONTACT

+44(1332)724612saad@amer@nottigham.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor in Gynaecology

Study Record Dates

First Submitted

August 25, 2011

First Posted

August 30, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2012

Study Completion

February 1, 2013

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations

GB(1)