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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Treatments: Cyproterone; Cyproterone Acetate; Cyproterone acetate, ethinyl estradiol drug combination

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.