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the Effect of Diane-35 Pretreatment on In-vitro Fertilization Outcome for Patients With Polycystic Ovary Syndrome

NCT ID: NCT01752270

Last Updated: 2012-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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diane-35

Diane-35 pretreatment from the third day of menstrual cycle

Group Type EXPERIMENTAL

Diane-35 pretreatment

Intervention Type DRUG

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 pretreatment

Intervention Type DRUG

blank control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diane-35 pretreatment

Diane-35 is applied from the third day of menstrual cycle for 21 days with a 7-day interval, for 3 consecutive cycles.

Intervention Type DRUG

Diane-35 pretreatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* oral contraceptive pills contraindications, eg.Deep Venous Thrombosis
* smoking, drunk
* exclude other infertile factors, eg.endometriosis, abnormal thyroid function, etc.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhou Canquan

vice president

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Sun Yatsen University

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital of Sun Yatsen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Xiaokun Hu

Role: CONTACT

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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sunyatsen8362

Identifier Type: -

Identifier Source: org_study_id