EndometriosisNCT02754648
Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve
A study testing laparoscopic ovarian endometriotic cyst in people with Endometriosis, run by Ain Shams University.
Trial summary
Is ovarian reserve and fecundity rate higher with laparoscopic ovarian aspiration rather than laparoscopic ovarian cystectomy and laparoscopic ovarian de-roofing in infertile woman with ovarian endometrioma or not? Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- laparoscopic ovarian endometriotic cyst
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 2016
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile woman aged 18-35 years old.
- Endometriotic ovarian cyst with size less than or equal 5 cm.
Who cannot join
- Other than included criteria.
About this study
Is ovarian reserve and fecundity rate higher with laparoscopic ovarian aspiration rather than laparoscopic ovarian cystectomy and laparoscopic ovarian de-roofing in infertile woman with ovarian endometrioma or not?
Read the detailed description
Primary objective:
To assess antral follicular count before and after treatment of endometriotic cyst either by aspiration, stripping, de-roofing and bed cauterization.
Secondary objectives To assess anti mullerian hormone level, follicle stimulating hormone level ,Doppler blood flow before and after treatment of endometriotic cyst either by aspiration, stripping, de-roofing and bed cauterization.
- Conditions
- Endometriosis
- Being tested
- laparoscopic ovarian endometriotic cyst
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic ovarian endometriotic cystProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A; laparoscopic ovarian endometrial aspiration | Active comparator | Laparoscopic ovarian endometrial aspiration will be done for thirty patients with ovarian endometriotic cyst. . Receives: Procedure: laparoscopic ovarian endometriotic cyst |
| group B; laparoscopic ovarian endometrial stripping | Active comparator | Laparoscopic ovarian endometrial stripping will be done for thirty patients with ovarian endometriotic cyst. Receives: Procedure: laparoscopic ovarian endometriotic cyst |
| Group c laparoscopic ovarian endometrial de-roofing | Active comparator | Laparoscopic ovarian endometrial de-roofing and bed cauterization will be done for thirty patients with ovarian endometriotic cyst. Receives: Procedure: laparoscopic ovarian endometriotic cyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
The antral follicular count which records the number of visible ovarian follicle (2-10 mm mean diameter) seen by transvaginal ultrasound on menstrual cycle( days 2_5)
Cut point(3-10)
Measured: One month
Secondary outcomes (2)
Anti mullerian hormone level in blood secreted by antral follicles 2-6 mm diameter in ovary
Measure in ng/ml cut point is( 0.2-0.7)
Measured: One month
Follicle stimulating hormone in blood secreted by antral follicles on day 2-4 of menstrual cycle
Cut point is(10-20) measured in international unit/litre
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Hassan Elbohoty, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754648
- Sponsor's protocol ID
- Ain ShamsU Laparoscopic Unit
- Status last verified
- Apr 2016
- First submitted
- 16 Mar 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve
- ClinicalTrials.gov ID
- NCT02754648
- Acronym / sponsor ID
- Ain ShamsU Laparoscopic Unit
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 28 Apr 2016 (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.
Is ovarian reserve and fecundity rate higher with laparoscopic ovarian aspiration rather than laparoscopic ovarian cystectomy and laparoscopic ovarian de-roofing in infertile woman with ovarian endometrioma or not?
Detailed description
Primary objective:
To assess antral follicular count before and after treatment of endometriotic cyst either by aspiration, stripping, de-roofing and bed cauterization.
Secondary objectives To assess anti mullerian hormone level, follicle stimulating hormone level ,Doppler blood flow before and after treatment of endometriotic cyst either by aspiration, stripping, de-roofing and bed cauterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A; laparoscopic ovarian endometrial aspiration | Active comparator | Procedure: laparoscopic ovarian endometriotic cystLaparoscopic ovarian endometrial aspiration will be done for thirty patients with ovarian endometriotic cyst. . |
| group B; laparoscopic ovarian endometrial stripping | Active comparator | Procedure: laparoscopic ovarian endometriotic cystLaparoscopic ovarian endometrial stripping will be done for thirty patients with ovarian endometriotic cyst. |
| Group c laparoscopic ovarian endometrial de-roofing | Active comparator | Procedure: laparoscopic ovarian endometriotic cystLaparoscopic ovarian endometrial de-roofing and bed cauterization will be done for thirty patients with ovarian endometriotic cyst. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Infertile woman aged 18-35 years old.
- Endometriotic ovarian cyst with size less than or equal 5 cm.
Key exclusion criteria (1 listed)
- Other than included criteria.
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 |
|---|---|---|
| laparoscopic ovarian endometriotic cyst | Procedure or surgery | Group A; laparoscopic ovarian endometrial aspiration, Group c laparoscopic ovarian endometrial de-roofing, group B; laparoscopic ovarian endometrial stripping |
Primary outcome
The antral follicular count which records the number of visible ovarian follicle (2-10 mm mean diameter) seen by transvaginal ultrasound on menstrual cycle( days 2_5)
Time frame: One month
Cut point(3-10)
2 secondary outcomes
Anti mullerian hormone level in blood secreted by antral follicles 2-6 mm diameter in ovary
Time frame: One month
Follicle stimulating hormone in blood secreted by antral follicles on day 2-4 of menstrual cycle
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic ovarian endometriotic cyst in people with Endometriosis, run by Ain Shams University.
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 1 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The antral follicular count which records the number of visible ovarian follicle (2-10 mm mean diameter) seen by transvaginal ultrasound on menstrual cycle( days 2_5) (time frame: One month). 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 28 Apr 2016.