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

Phase 4

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Diane-35 pretreatment

• Registration Number: NCT01752270
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-12
• Study Start: 2012-12
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-16
• Last Update Submitted: 2012-12-16
• Study First Posted: 2012-12-19
• Last Update Posted: 2012-12-19
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diane-35	Diane-35 pretreatment	Diane-35 pretreatment from the third day of menstrual cycle

Primary Outcome Measures

Name	Time	Method
fertilization rate	up to 2years

Secondary Outcome Measures

Name	Time	Method
implantation rate	up to 2years

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yatsen University; 🇨🇳 Guangzhou, Guangdong, China