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

This study is not yet open for participant recruitment.
Verified December 2012 by First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01752270
First received: December 6, 2012
Last updated: December 16, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Polycystic Ovary Syndrome
 Drug: Diane-35 pretreatment
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • fertilization rate [ Time Frame: up to 2years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • implantation rate [ Time Frame: up to 2years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • clinical pregnancy rate [ Time Frame: up to 2years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752270

Contacts
Contact: Xiaokun Hu eoshappy@163.com

Locations
China, Guangdong
The First Affiliated Hospital of Sun Yatsen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact         eoshappy@163.com    
Principal Investigator: Canquan Zhou            
The First Affiliated Hospital of Sun Yatsen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Principal Investigator: Canquan Zhou            
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Zhou Canquan, vice president, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01752270     History of Changes
Other Study ID Numbers: sunyatsen8362
Study First Received: December 6, 2012
Last Updated: December 16, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Diane
Cyproterone
 Cyproterone Acetate
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 19, 2013