the Effect of Diane-35 Pretreatment on In-vitro Fertilization Outcome for Patients With Polycystic Ovary Syndrome
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Xiaokun Hu
Data sourced from clinicaltrials.gov
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