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

December 16, 2012 updated by: Zhou Canquan, First Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital of Sun Yatsen University
        • Principal Investigator:
          • Canquan Zhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fertilization rate
Time Frame: up to 2years
up to 2years

Secondary Outcome Measures

Outcome Measure
Time Frame
implantation rate
Time Frame: up to 2years
up to 2years

Other Outcome Measures

Outcome Measure
Time Frame
clinical pregnancy rate
Time Frame: up to 2years
up to 2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

December 6, 2012

First Submitted That Met QC Criteria

December 16, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 16, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sunyatsen8362

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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