The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve

NCT ID: NCT01425333

Last Updated: 2011-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cystectomy

Patients undergoing cystectomy for ovarian endometrioma

Group Type ACTIVE_COMPARATOR

Surgery for ovarian endometrioma

Intervention Type PROCEDURE

Patients undergoing surgery for ovarian endometrioma

Ablation

Patients undergoing ablation for ovarian endometrioma

Group Type ACTIVE_COMPARATOR

Surgery for ovarian endometrioma

Intervention Type PROCEDURE

Patients undergoing surgery for ovarian endometrioma

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgery for ovarian endometrioma

Patients undergoing surgery for ovarian endometrioma

Intervention Type PROCEDURE

Surgery for ovarian endometrioma

Patients undergoing surgery for ovarian endometrioma

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Patients undergoing cystectomy for ovarian endometrioma Patients undergoing cystectomy for ovarian endometrioma

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role collaborator

Saad Amer

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Saad Amer

Associate Professor in Gynaecology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Saad Amer, MD, MRCOG

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham and Derby Hospitals NHS foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Derby Hospital

Derby, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Saad Amer, MD, MRCOG

Role: CONTACT

+44(1332)724612

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Saad Amer, MD, MRCOG

Role: primary

+44(1332)724612

Francesca Raffi, MBChB, MRCOG

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R&D: DHRD/2010/089

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Conservative Endometrioma Surgery
NCT04151433 RECRUITING NA