Polycystic Ovary SyndromeNCT03157921
Prevalence of Pregnancy in Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
Polycystic ovary syndrome is the most common endocrine disorder in women of reproductive age, with a prevalence of approximately 5-10%. Polycystic ovary syndrome is diagnosed according to Rotterdam criteria by at least two of the following three key features: oligomenorrhea or amenorrhea; clinical and/or biochemical… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- transvaginal ultrasound and Hormonal levels
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to May 2017
- 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 18 to 40 years
- Women only
- Adult
Study population: infertile women with poly-cystic ovary syndrome
Who may be able to join
- infertile women
- age from 18 to 40 years
- poly-cystic ovary syndrome
- Body mass index 18.5-35 kg/m2
Who cannot join
- Endocrine disorders (cushing syndrome-congenital adrenal hyperplasia)
- Systemic disease
- Use of oral contraceptive,glucocorticoid and antiandrogen
- Use of ovulation induction or dopaminergic agents
- Use of antidiabetes, anti obesity drugs
- history of tubal or ovarian surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Spontaneous Ovulation and Pregnancy in Patients With Polycystic Ovary Syndrome
Polycystic ovary syndrome is the most common endocrine disorder in women of reproductive age, with a prevalence of approximately 5-10%. Polycystic ovary syndrome is diagnosed according to Rotterdam criteria by at least two of the following three key features: oligomenorrhea or amenorrhea; clinical and/or biochemical signs of hyperandrogenism; the presence of polycystic ovaries on ultrasound and exclusion of other endocrine disorders including hyperprolactinemia, thyroid dysfunction and congenital adrenal hyperplasia. Polycystic ovary syndrome is also associated with insulin resistance, obesity and disorders of lipid metabolism, as well as infertility, although these findings have not been addressed in the Rotterdam criteria. Polycystic ovary syndrome is the major cause of anovulatory infertility. The recent studies suggest that anovulation resulting from ovarian follicle abnormalities in Polycystic ovary syndrome patients are 2-fold of normal ovaries. Firstly, early follicular growth is excessive, thus women with Polycystic ovary syndrome are characterized by an excessive number of small antral follicles (2- to 3-fold of normal ovaries). Secondly, the selection of one follicle from the increased pool of selectable follicles and its further maturation to a dominant follicle does not occur. This second abnormality in the folliculogenesis can cause menstrual dysfunction presented as oligomenorrhea or amenorrhea. Historically, Polycystic ovary syndrome treatment has not been curative in nature, instead treatments focus on resolution of clinical manifestations of the disease.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- transvaginal ultrasound, Hormonal levels
- 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.
transvaginal ultrasoundRadiation
assessment of ovarian volume and antral follicle count
Hormonal levelsDiagnostic test
follicle stimulating hormone level, luteinizing hormone level and anti-mullerian hormone level
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of poly-cystic ovarian syndrome women who will be ovulated
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 posted17 May 2017
- Study startApr 2016
- Primary completionApr 2017
- Study completionMay 2017
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157921
- Sponsor's protocol ID
- 17100186
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Spontaneous Ovulation and Pregnancy in Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03157921
- Acronym / sponsor ID
- 17100186
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 May 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.
Polycystic ovary syndrome is the most common endocrine disorder in women of reproductive age, with a prevalence of approximately 5-10%. Polycystic ovary syndrome is diagnosed according to Rotterdam criteria by at least two of the following three key features: oligomenorrhea or amenorrhea; clinical and/or biochemical signs of hyperandrogenism; the presence of polycystic ovaries on ultrasound and exclusion of other endocrine disorders including hyperprolactinemia, thyroid dysfunction and congenital adrenal hyperplasia. Polycystic ovary syndrome is also associated with insulin resistance, obesity and disorders of lipid metabolism, as well as infertility, although these findings have not been addressed in the Rotterdam criteria. Polycystic ovary syndrome is the major cause of anovulatory infertility. The recent studies suggest that anovulation resulting from ovarian follicle abnormalities in Polycystic ovary syndrome patients are 2-fold of normal ovaries. Firstly, early follicular growth is excessive, thus women with Polycystic ovary syndrome are characterized by an excessive number of small antral follicles (2- to 3-fold of normal ovaries). Secondly, the selection of one follicle from the increased pool of selectable follicles and its further maturation to a dominant follicle does not occur. This second abnormality in the folliculogenesis can cause menstrual dysfunction presented as oligomenorrhea or amenorrhea. Historically, Polycystic ovary syndrome treatment has not been curative in nature, instead treatments focus on resolution of clinical manifestations of the disease.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- infertile women with poly-cystic ovary syndrome
Key inclusion criteria (4 listed)
- infertile women
- age from 18 to 40 years
- poly-cystic ovary syndrome
- Body mass index 18.5-35 kg/m2
Key exclusion criteria (6 listed)
- Endocrine disorders (cushing syndrome-congenital adrenal hyperplasia)
- Systemic disease
- Use of oral contraceptive,glucocorticoid and antiandrogen
- Use of ovulation induction or dopaminergic agents
- Use of antidiabetes, anti obesity drugs
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 |
|---|---|---|
| transvaginal ultrasoundassessment of ovarian volume and antral follicle count | Radiation | – |
| Hormonal levelsfollicle stimulating hormone level, luteinizing hormone level and anti-mullerian hormone level | Diagnostic test | – |
Primary outcome
Number of poly-cystic ovarian syndrome women who will be ovulated
Time frame: 3 months
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 17 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Assiut University 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 4 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 17 May 2017. 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?
Number of poly-cystic ovarian syndrome women who will be ovulated (time frame: 3 months). 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 17 May 2017.