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

Polycystic Ovary Syndrome Clinical Trial

Official title:

The Effect of Diane-35 Pretreatment on Endocrine and Clinical Profile for Patients With Polycystic Ovary Syndrome Undergoing In-vitro Fertilization

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01752270
• Other study ID #: sunyatsen8362
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 6, 2012
• Last updated: December 16, 2012
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2012
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Xiaokun Hu
• Email: eoshappy[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• 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.
• Diane-35 pretreatment

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yatsen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Sun Yatsen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	clinical pregnancy rate		up to 2years	Yes
Primary	fertilization rate		up to 2years	Yes
Secondary	implantation rate		up to 2years	Yes