the Effect of Diane-35 Pretreatment on In-vitro Fertilization Outcome for Patients With Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Diane-35 pretreatment
Diane-35 pretreatment
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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.
Sites / Locations
- The First Affiliated Hospital of Sun Yatsen University
- The First Affiliated Hospital of Sun Yatsen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
diane-35
blank control
Arm Description
Diane-35 pretreatment from the third day of menstrual cycle
Outcomes
Primary Outcome Measures
fertilization rate
Secondary Outcome Measures
implantation rate
Full Information
NCT ID
NCT01752270
First Posted
December 6, 2012
Last Updated
December 16, 2012
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT01752270
Brief Title
the Effect of Diane-35 Pretreatment on In-vitro Fertilization Outcome for Patients With Polycystic Ovary Syndrome
Official Title
The Effect of Diane-35 Pretreatment on Endocrine and Clinical Profile for Patients With Polycystic Ovary Syndrome Undergoing In-vitro Fertilization
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
diane-35
Arm Type
Experimental
Arm Description
Diane-35 pretreatment from the third day of menstrual cycle
Arm Title
blank control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Diane-35 pretreatment
Intervention Description
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
Intervention Name(s)
Diane-35 pretreatment
Primary Outcome Measure Information:
Title
fertilization rate
Time Frame
up to 2years
Secondary Outcome Measure Information:
Title
implantation rate
Time Frame
up to 2years
Other Pre-specified Outcome Measures:
Title
clinical pregnancy rate
Time Frame
up to 2years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaokun Hu
Email
eoshappy@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yatsen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Contact:
Email
eoshappy@163.com
First Name & Middle Initial & Last Name & Degree
Canquan Zhou
Facility Name
The First Affiliated Hospital of Sun Yatsen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Canquan Zhou
12. IPD Sharing Statement
Learn more about this trial
the Effect of Diane-35 Pretreatment on In-vitro Fertilization Outcome for Patients With Polycystic Ovary Syndrome
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