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

Sponsor

First Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01752270

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Diane-35 pretreatment Drug: Diane-35 pretreatment	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: diane-35 Diane-35 pretreatment from the third day of menstrual cycle	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. Drug: Diane-35 pretreatment
No Intervention: blank control

Arm

Intervention/Treatment

Experimental: diane-35

Diane-35 pretreatment from the third day of menstrual cycle

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.

Drug: Diane-35 pretreatment

No Intervention: blank control

Outcome Measures

Primary Outcome Measures

fertilization rate [up to 2years]

Secondary Outcome Measures

implantation rate [up to 2years]

Other Outcome Measures

clinical pregnancy rate [up to 2years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Sun Yatsen University	Guangzhou	Guangdong	China	510080
2	The First Affiliated Hospital of Sun Yatsen University	Guangzhou	Guangdong	China	510080