EndometriosisNCT01425333
The Impact of Surgical Treatment of Endometriomas on Ovarian Reserve
A study testing Surgery for ovarian endometrioma in people with Endometriosis, run by Saad Amer at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- What is being tested?
- Surgery for ovarian endometrioma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing laparoscopic surgery for treatment of unilateral endometriomas measuring ≥ 3cm and ≤ 8cm in diameter
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Derby Hospital
Derby, DE22 3NE
Saad Amer, MD, MRCOG, +44(1332)724612, saad.amer@nottingham.ac.uk
Francesca Raffi, MBChB, MRCOG
About this study
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
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.
- Conditions
- Endometriosis
- Being tested
- Surgery for ovarian endometrioma
- Keywords
- Ovarian endometriomas, Laparoscopy, Cystectomy, Ablation
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for ovarian endometriomaProcedure or surgery
Also called Patients undergoing cystectomy for ovarian endometrioma
Patients undergoing surgery for ovarian endometrioma
Surgery for ovarian endometriomaProcedure or surgery
Also called Patients undergoing cystectomy for ovarian endometrioma
Patients undergoing surgery for ovarian endometrioma
| Study group | Role | What they receive |
|---|---|---|
| Cystectomy | Active comparator | Patients undergoing cystectomy for ovarian endometrioma Receives: Procedure: Surgery for ovarian endometrioma |
| Ablation | Active comparator | Patients undergoing ablation for ovarian endometrioma Receives: Procedure: Surgery for ovarian endometrioma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Mullerian Hormone (AMH)
Change in anti-mullerian hormone level after surgery (at one week, three months and six months)
Measured: 6 months post-operatively
Secondary outcomes (2)
Follicle Stimulating Hormone (FSH)
Change in follicle stimulating hormone levels after surgery (at one week, three months and six months)
Measured: 6 months
Antral Follicle Count (AFC)
Change in AFC after surgery (at three months)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saad Amer
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Saad Amer, University Hospitals of Derby and Burton NHS Foundation Trust
- Investigators
- Saad Amer, MD, MRCOG, Principal investigator, University of Nottingham and Derby Hospitals NHS foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425333
- Sponsor's protocol ID
- R&D: DHRD/2010/089
- Status last verified
- Aug 2011
- First submitted
- 25 Aug 2011
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01425333
- Acronym / sponsor ID
- R&D: DHRD/2010/089
- Conditions
- Endometriosis
- Keywords
- Ovarian endometriomas, Laparoscopy, Cystectomy, Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Saad AmerUniversity, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cystectomy | Active comparator | Procedure: Surgery for ovarian endometriomaPatients undergoing cystectomy for ovarian endometrioma |
| Ablation | Active comparator | Procedure: Surgery for ovarian endometriomaPatients undergoing ablation for ovarian endometrioma |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women undergoing laparoscopic surgery for treatment of unilateral endometriomas measuring ≥ 3cm and ≤ 8cm in diameter
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for ovarian endometriomaAlso: Patients undergoing cystectomy for ovarian endometriomaPatients undergoing surgery for ovarian endometrioma | Procedure or surgery | Cystectomy |
| Surgery for ovarian endometriomaAlso: Patients undergoing cystectomy for ovarian endometriomaPatients undergoing surgery for ovarian endometrioma | Procedure or surgery | Ablation |
Primary outcome
Anti-Mullerian Hormone (AMH)
Time frame: 6 months post-operatively
Change in anti-mullerian hormone level after surgery (at one week, three months and six months)
2 secondary outcomes
Follicle Stimulating Hormone (FSH)
Time frame: 6 months
Antral Follicle Count (AFC)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saad Amer, MD, MRCOG principal investigator
University of Nottingham and Derby Hospitals NHS foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery for ovarian endometrioma in people with Endometriosis, run by Saad Amer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saad Amer, MD, MRCOG (+44(1332)724612, saad@amer@nottigham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Mullerian Hormone (AMH) (time frame: 6 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2011; AzTrials last refreshed its copy on 8 Nov 2026.