Polycystic Ovary SyndromeNCT03326024
The Ovarian Reserve and Laparoscopic Ovarian Drilling
An observational study of Polycystic Ovary Syndrome, run by Assiut University.
Trial summary
Long term assessment of ovarian reserve after more than two years of laparoscopic ovarian drilling in Polycystic Ovary Syndrome Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 Oct 2018
- Phase
- Observational
- 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 35 years
- Women only
- Adult
Study population: OUPATIENT CLINICS OF women health hospital - Assiut university
Who may be able to join
- Goup "A": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years.
- Goup "B": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling
Who cannot join
- Age <19 or > 35 years.
- BMI <19 or > 35
- patients refusing to participate in the study.
- previous ovarian cystectomy.
About this study
Official title: Long Term Assessment of Ovarian Reserve After More Than Two Years of Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome
Long term assessment of ovarian reserve after more than two years of laparoscopic ovarian drilling in Polycystic Ovary Syndrome
Read the detailed description
Inclusion criteria:
Goup "A": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years.
Goup "B": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling
Anti-mullerian hormone (as an indicator for ovarian reserve) will be measured for the two groups and data collected will be compared
- Conditions
- Polycystic Ovary Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Patients with Polycystic Ovary Syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years. | |
| B | Patients with Polycystic Ovary Syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of anti-mullerian hormone after laparoscopic ovarian drilling
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Salama, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326024
- Sponsor's protocol ID
- 17100367
- Status last verified
- Oct 2017
- First submitted
- 20 Oct 2017
- Last updated
- 30 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Assessment of Ovarian Reserve After More Than Two Years of Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03326024
- Acronym / sponsor ID
- 17100367
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 30 Oct 2017 (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.
Long term assessment of ovarian reserve after more than two years of laparoscopic ovarian drilling in Polycystic Ovary Syndrome
Detailed description
Inclusion criteria:
Goup "A": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years.
Goup "B": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling
Anti-mullerian hormone (as an indicator for ovarian reserve) will be measured for the two groups and data collected will be compared
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Patients with Polycystic Ovary Syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years. |
| B | – | –Patients with Polycystic Ovary Syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- OUPATIENT CLINICS OF women health hospital - Assiut university
Key inclusion criteria (2 listed)
- Goup "A": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and underwent laparoscopic ovarian drilling from more than two years.
- Goup "B": Patients with polycystic ovary syndrome at reproductive age (20-35) diagnosed according to Rotterdam criteria and didn't undergo laparoscopic ovarian drilling
Key exclusion criteria (4 listed)
- Age <19 or > 35 years.
- BMI <19 or > 35
- patients refusing to participate in the study.
- previous ovarian cystectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of anti-mullerian hormone after laparoscopic ovarian drilling
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
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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?
An observational study of Polycystic Ovary Syndrome, run by Assiut 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 4 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 Oct 2017. 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?
Level of anti-mullerian hormone after laparoscopic ovarian drilling (time frame: 2 years). 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 Oct 2017.