Polycystic Ovary SyndromePhase 4NCT01752270
the Effect of Diane-35 Pretreatment on In-vitro Fertilization Outcome for Patients With Polycystic Ovary Syndrome
A Phase 4 study testing Diane-35 pretreatment in people with Polycystic Ovary Syndrome, run by First Affiliated Hospital, Sun Yat-Sen University at 2 sites in China.
Trial summary
Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to affect more than 5% of the population and is associated with chronically elevated serum androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative impact on pregnancy outcomes, with an increased risk… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Diane-35 pretreatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2012to Dec 2014
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed polycystic ovary syndrome patients according to Rotterdam criteria
- with hyperandrogenism and/or clinical hyperandrogenic manifestations
- no other oral contraceptives treatment for at least 3 months before this experiment
- no any other assisted reproductive therapy
- accompanied with fallopian tube and/or male factors
- normal hepato-/nephro- function
Who cannot join
- oral contraceptive pills contraindications, eg.Deep Venous Thrombosis
- smoking, drunk
- exclude other infertile factors, eg.endometriosis, abnormal thyroid function, etc.
Trial locations and contacts
2 sites in 1 country.
Xiaokun Hu contact
China2 sites
The First Affiliated Hospital of Sun Yatsen University
Guangzhou, Guangdong, 510080
eoshappy@163.com
Canquan Zhou
The First Affiliated Hospital of Sun Yatsen University
Guangzhou, Guangdong, 510080
Canquan Zhou
About this study
Official title: The Effect of Diane-35 Pretreatment on Endocrine and Clinical Profile for Patients With Polycystic Ovary Syndrome Undergoing In-vitro Fertilization
Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to affect more than 5% of the population and is associated with chronically elevated serum androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative impact on pregnancy outcomes, with an increased risk of gestational diabetes, hypertensive disease during pregnancy,and preterm birth,which is partially related with the hyperandrogenic environment.Diane-35 has been proved to be the most effective anti-androgenic drug.At present, there is no direct evidence that Diane-35 has a positive effect on the clinical outcome of polycystic ovary syndrome patients undergoing In-vitro fertilization/Intracytoplasmic sperm injection.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Diane-35 pretreatment
- 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.
Diane-35 pretreatmentDrug
Diane-35 is applied from the third day of menstrual cycle for 21 days with a 7-day interval, for 3 consecutive cycles.
Diane-35 pretreatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| diane-35 | Experimental | Diane-35 pretreatment from the third day of menstrual cycle Receives: Drug: Diane-35 pretreatment |
| blank control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
fertilization rate
Measured: up to 2years
Secondary outcomes (1)
implantation rate
Measured: up to 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (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 First Affiliated Hospital, Sun Yat-Sen 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752270
- Sponsor's protocol ID
- sunyatsen8362
- Status last verified
- Dec 2012
- First submitted
- 6 Dec 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diane-35 Pretreatment on Endocrine and Clinical Profile for Patients With Polycystic Ovary Syndrome Undergoing In-vitro Fertilization
- ClinicalTrials.gov ID
- NCT01752270
- Acronym / sponsor ID
- sunyatsen8362
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 19 Dec 2012 (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.
Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to affect more than 5% of the population and is associated with chronically elevated serum androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative impact on pregnancy outcomes, with an increased risk of gestational diabetes, hypertensive disease during pregnancy,and preterm birth,which is partially related with the hyperandrogenic environment.Diane-35 has been proved to be the most effective anti-androgenic drug.At present, there is no direct evidence that Diane-35 has a positive effect on the clinical outcome of polycystic ovary syndrome patients undergoing In-vitro fertilization/Intracytoplasmic sperm injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diane-35 | Experimental | Drug: Diane-35 pretreatmentDiane-35 pretreatment from the third day of menstrual cycle |
| blank control | No intervention | – |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- diagnosed polycystic ovary syndrome patients according to Rotterdam criteria
- with hyperandrogenism and/or clinical hyperandrogenic manifestations
- no other oral contraceptives treatment for at least 3 months before this experiment
- no any other assisted reproductive therapy
- accompanied with fallopian tube and/or male factors
Key exclusion criteria (3 listed)
- oral contraceptive pills contraindications, eg.Deep Venous Thrombosis
- smoking, drunk
- exclude other infertile factors, eg.endometriosis, abnormal thyroid function, etc.
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 |
|---|---|---|
| Diane-35 pretreatmentDiane-35 is applied from the third day of menstrual cycle for 21 days with a 7-day interval, for 3 consecutive cycles. | Drug | diane-35 |
| Diane-35 pretreatment | Drug | diane-35 |
Primary outcome
fertilization rate
Time frame: up to 2years
1 secondary outcome
implantation rate
Time frame: up to 2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
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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.
Xiaokun Hu contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diane-35 pretreatment in people with Polycystic Ovary Syndrome, run by First Affiliated Hospital, Sun Yat-Sen University at 2 sites in China.
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 6 inclusion and 3 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 19 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaokun Hu (eoshappy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fertilization rate (time frame: up to 2years). 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 19 Dec 2012.