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

NCT01752270 | Unknown Phase 4

• 1 other identifier: sunyatsen8362
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• fertilization rate

  up to 2years

Secondary Outcomes (1)

• implantation rate

  up to 2years

Other Outcomes (1)

• clinical pregnancy rate

  up to 2years

Study Arms (2)

diane-35

EXPERIMENTAL

Diane-35 pretreatment from the third day of menstrual cycle

Drug: Diane-35 pretreatment

blank control

NO INTERVENTION

Interventions

Diane-35 pretreatment DRUG

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

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• oral contraceptive pills contraindications, eg.Deep Venous Thrombosis
• smoking, drunk
• exclude other infertile factors, eg.endometriosis, abnormal thyroid function, etc.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (2)

The First Affiliated Hospital of Sun Yatsen University

Guangzhou, Guangdong, 510080, China

Location

The First Affiliated Hospital of Sun Yatsen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Xiaokun Hu

CONTACT

eoshappy@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 19, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 19, 2012

Record last verified: 2012-12

Locations

CN (2)