Ovarian EndometriomaNCT03615352
Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma
A study testing ovarian cystectomy and ovarian cyst aspiration and coagulation in people with Ovarian Endometrioma, run by Shaimaa Mostafa Mohammed Refaay El shemy at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on ovarian reserve and pelvic pain in cases of ovarian endometrioma. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Ovarian Endometrioma
- What is being tested?
- ovarian cystectomy and ovarian cyst aspiration and coagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Oct 2018
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female with age group 20-40 years.
- Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥3cm.
Who cannot join
- Previous ovarian surgery.
- Endocrinological diseases affecting ovarian reserve e.g. Diabetes mellitus, hypothyroidism.
- Polycystic ovary syndrome (PCO).
- Suspicion of ovarian malignancy by ultrasound.
- Other pelvic pathology e.g. uterine fibroid, pelvic inflammatory disease (PID).
- High basal FSH >10mIU/mL (milli-international unit per milliliter).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation on Ovarian Reserve and Pelvic Pain in Cases of Ovarian Endometrioma
The aim of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on ovarian reserve and pelvic pain in cases of ovarian endometrioma.
Read the detailed description
All patients are presenting with ovarian endometrioma. They are all subjected to informed written consent, full history, general examination, local examination and transvaginal ultrasound. Follicular stimulating hormone (FSH), Lutenizing hormone (LH), Anti Mullerian hormone (AMH), Antral follicular count (AFC) and chronic pelvic pain which is assessed by Visual Analogue Scale (VAS) of pain scoring system ,all are to be determined before and after laparoscopic surgery (postoperative three months); for two groups (Group A) cystectomy and (Group B) aspiration and coagulation. Histopathological examination was done to the cystectomy group to confirm endometriosis and detect the presence of healthy ovarian tissue in the excised cyst wall.
- Conditions
- Ovarian Endometrioma
- Being tested
- ovarian cystectomy, ovarian cyst aspiration and coagulation
- Keywords
- Endometrioma, laparoscopy, ovarian reserve, pelvic pain
- Medical subject headings
- Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ovarian cystectomyProcedure or surgery
laparoscopic ovarian cystectomy in endometrioma
ovarian cyst aspiration and coagulationProcedure or surgery
laparoscopic ovarian cyst aspiration and coagulation in endometrioma
| Study group | Role | What they receive |
|---|---|---|
| ovarian cystectomy | Experimental | laparoscopic ovarian cystectomy in endometrioma Receives: Procedure: ovarian cystectomy |
| ovarian cyst aspiration and coagulation | Experimental | laparoscopic ovarian endometrioma aspiration and coagulation Receives: Procedure: ovarian cyst aspiration and coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve .
Evaluation of ovarian reserve which is measured by Anti Mullerian hormone (AMH) in nano-gram per milliliter (ng/ml) before laparoscopy and after the surgery by 3 months.
Measured: 3 months after laparoscopy
Secondary outcomes (2)
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Antral Follicular Count (AFC) as a measurement of ovarian reserve.
Evaluation of ovarian reserve by assessment of Antral Follicular Count (AFC) by measuring the number of visible ovarian follicles (2-10 mm mean diameter) that are observed during transvaginal ultrasonography in the early follicular phase (cycle days 2-5) in both ovaries. It is done before laparoscopy and after the surgery by 3 months.
Measured: 3 months after laparoscopy
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on chronic pelvic pain.
Pelvic pain is measured by Visual analogue scale of pain (VAS) which is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10-cm scale).
The pelvic pain is assessed before laparoscopy and after laparoscopy by 3 months.
Measured: 3 months after laparoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Jan 2018
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian EndometriomaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaimaa Mostafa Mohammed Refaay El shemy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shaimaa Mostafa Mohammed Refaay El shemy, Cairo University
- Investigators
- Mohammed Zayed Abd Elaziz, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615352
- Sponsor's protocol ID
- Laparoscopy in endometrioma
- Status last verified
- Jan 2019
- First submitted
- 21 Jul 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation on Ovarian Reserve and Pelvic Pain in Cases of Ovarian Endometrioma
- ClinicalTrials.gov ID
- NCT03615352
- Acronym / sponsor ID
- Laparoscopy in endometrioma
- Conditions
- Ovarian Endometrioma
- Keywords
- Endometrioma, laparoscopy, ovarian reserve, pelvic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Shaimaa Mostafa Mohammed Refaay El shemyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 3 Aug 2018 (actual)
- 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 evaluate the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on ovarian reserve and pelvic pain in cases of ovarian endometrioma.
Detailed description
All patients are presenting with ovarian endometrioma. They are all subjected to informed written consent, full history, general examination, local examination and transvaginal ultrasound. Follicular stimulating hormone (FSH), Lutenizing hormone (LH), Anti Mullerian hormone (AMH), Antral follicular count (AFC) and chronic pelvic pain which is assessed by Visual Analogue Scale (VAS) of pain scoring system ,all are to be determined before and after laparoscopic surgery (postoperative three months); for two groups (Group A) cystectomy and (Group B) aspiration and coagulation. Histopathological examination was done to the cystectomy group to confirm endometriosis and detect the presence of healthy ovarian tissue in the excised cyst wall.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ovarian cystectomy | Experimental | Procedure: ovarian cystectomylaparoscopic ovarian cystectomy in endometrioma |
| ovarian cyst aspiration and coagulation | Experimental | Procedure: ovarian cyst aspiration and coagulationlaparoscopic ovarian endometrioma aspiration and coagulation |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female with age group 20-40 years.
- Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥3cm.
Key exclusion criteria (6 listed)
- Previous ovarian surgery.
- Endocrinological diseases affecting ovarian reserve e.g. Diabetes mellitus, hypothyroidism.
- Polycystic ovary syndrome (PCO).
- Suspicion of ovarian malignancy by ultrasound.
- Other pelvic pathology e.g. uterine fibroid, pelvic inflammatory disease (PID).
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 |
|---|---|---|
| ovarian cystectomylaparoscopic ovarian cystectomy in endometrioma | Procedure or surgery | ovarian cystectomy |
| ovarian cyst aspiration and coagulationlaparoscopic ovarian cyst aspiration and coagulation in endometrioma | Procedure or surgery | ovarian cyst aspiration and coagulation |
Primary outcome
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve .
Time frame: 3 months after laparoscopy
Evaluation of ovarian reserve which is measured by Anti Mullerian hormone (AMH) in nano-gram per milliliter (ng/ml) before laparoscopy and after the surgery by 3 months.
2 secondary outcomes
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Antral Follicular Count (AFC) as a measurement of ovarian reserve.
Time frame: 3 months after laparoscopy
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on chronic pelvic pain.
Time frame: 3 months after laparoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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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.
Mohammed Zayed Abd Elaziz, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ovarian cystectomy and ovarian cyst aspiration and coagulation in people with Ovarian Endometrioma, run by Shaimaa Mostafa Mohammed Refaay El shemy at 1 site in Egypt.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 31 Jan 2019. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve . (time frame: 3 months after laparoscopy). 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 31 Jan 2019.